Associate Director, Medical Coding
Job Title: Associate Director, Medical Coding Location: Philadelphia (On-site) This is an exciting opportunity for an experienced medical coding professional with strong leadership skills and a solid understanding of regulatory compliance and guidelines. Key Responsibilities: Lead, mentor, and manage a team of Clinical Data Managers/Coders, providing guidance, training, and support to ensure high-quality and accurate coding. Develop, implement, and optimize coding processes to improve efficiency, reduce errors, and enhance departmental productivity. Cross-Departmental Collaboration - Provide expert advice to optimize technology and support efficiency Qualifications: Health Science Degree (ex. Nursing, Pharmacy, etc.) is preferred 8+ years of Industry Experience as a Medical Coder and/or as a Clinical Data Manager (Industry Experience - Pharmaceutical/Biotechnology/CRO) Experience with CRO/Vendor Oversight Knowledge of ICH-GCP guidelines Strong understanding of medical terminology. Experience with Clinical trial data systems and/or EDC
US$140000 - US$200000 per year
Philadelphia
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Snr Director Statistical Programming
We have a current opportunity for a Snr Director Statistical Programming on a permanent basis. The position will be based in California or Massachusetts. For further information about this position please apply. Job Title: Senior Director of Statistical Programming Salary: $230,000-$260,000 base Position Overview: We are seeking an experienced and highly motivated Senior Director of Statistical Programming to lead our statistical programming team. This role is critical to our clinical development efforts and will involve overseeing the design, development, and implementation of statistical programming activities for our clinical trials. Key Responsibilities: Lead and manage the statistical programming team, providing mentorship and guidance to junior programmers. Oversee the development, validation, and maintenance of SAS programs to support clinical trial data analysis and reporting. Collaborate with biostatisticians, data managers, and clinical teams to ensure the accuracy and integrity of clinical trial data. Develop and implement standard operating procedures (SOPs) for statistical programming activities. Ensure compliance with regulatory requirements and industry standards (e.g., CDISC, FDA, EMA). Participate in the preparation of statistical analysis plans (SAPs) and clinical study reports (CSRs). Provide strategic input on statistical programming aspects of clinical development plans. Stay current with industry trends and advancements in statistical programming methodologies. Qualifications: Advanced degree (Master's or Ph.D.) in Statistics, Mathematics, Biostatistics, Computer Science, or a related field. Minimum of 14 years of experience in statistical programming within the biotech or pharmaceutical industry. Proven leadership experience with a track record of managing and developing high-performing teams. Expertise in SAS programming and familiarity with other statistical software (e.g., R, Python) is a plus. Early and late stage clinical trial experience Regulatory interraction experience Strong knowledge of clinical trial design, data management, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. What We Offer: Competitive salary and benefits package. Opportunity to work in a fast-paced, innovative environment. Career growth and development opportunities. A supportive and inclusive company culture.
US$230000 - US$260000 per year
Massachusetts
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Senior Clinical Data Manager
Senior Clinical Data Manager San Diego, CA - Hybrid 110,000-145,000 A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. They are looking to hire a Senior Clinical Data Manager to support this advancement. Their advanced drug discovery platform uses cutting-edge technology to design highly targeted cancer therapies. This innovative approach aims to create precise treatments with improved efficacy and reduced side effects, driving their mission to revolutionize cancer care. Backed by over $200 million in funding from top-tier investors, the company is well-positioned for rapid growth. The leadership team includes an award-winning CEO recognized for entrepreneurial excellence and a CMO with a distinguished track record in precision medicine and immunotherapy. Joining this company means contributing to innovative cancer treatments within a dynamic, well-funded environment alongside passionate experts committed to transforming oncology. The Senior Clinical Data Manager responsibilities will include: * Lead data management activities and database build processes. * Monitor data collection, coding, and cleaning by vendors. * Oversee database lock activities and archiving of study data. * Collaborate with internal and external partners, including Biostatistics and Clinical Operations. * Review and manage CRO data management plans and study documentation. * Represent data management in cross-functional team meetings and with external vendors. * Mentor and train internal colleagues on data management activities. Qualifications * Bachelor's degree mandatory, with a minimum of 4 years hands-on data management experience in the CRO, biotech, or pharmaceutical sector. * Oncology experience required. * Strong vendor management skills If you are interested, please dont heasitate to apply.
US$110000 - US$145000 per year
San Diego
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Director, Clinical Data Management
Director, Clinical Data Management San Diego, CA - Hybrid 200,000-230,000 A clinical-stage cell therapy company in San Diego is expanding its clinical data management team. Specializing in treatments for autoimmune diseases and hematological cancers, the company employs a novel approach by utilizing Natural Killer (NK) cells that specifically target B cells. As pioneers in cell therapies, the team made one of the first IND filings for Lupus using cell therapy. Currently, they are advancing six indications, with four in clinical stages. The company is focused on streamlining manufacturing and distribution to improve access to innovative treatments. The CEO has over 20 years of experience in biotech and venture capital, with leadership roles in prominent life sciences companies, while the CMO has a strong background in clinical research from leading pharmaceutical firms. This role offers the chance to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology. Key Responsibilities Support the management of clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards, standard operating procedures (SOPs), and ICH/GCP guidelines. Help oversee essential trial aspects, including study start-up, patient enrollment, site interactions, and data management, proactively identifying and resolving issues. Draft and review key study documents, including informed consent forms, case report forms, study manuals, and other trial materials. Assist in selecting and managing study sites and evaluating CROs and other service providers, as well as overseeing contracts and budgets. Work towards project goals, managing timelines and deliverables to align with organizational objectives. Provide study updates to cross-functional teams and help address issues with sites and CROs through analysis and action planning. Contribute to the development of study tools and resources to enhance data quality and trial efficiency. Participate in training new team members on study processes as needed. Track study progress, maintain relevant metrics, and keep the team informed. Serve as a key point of contact for study sites, and participate in assessing and resolving any safety or patient care issues. Oversee and support contract and budget negotiations with clinical sites. Assist in planning and presenting at investigator and CRO training meetings. Conduct site visits as needed, including qualification, initiation, monitoring, and close-out visits; perform oversight visits to review and assess CRO activities. Support internal and external audits, helping to address and resolve any findings. Qualifications and Experience Bachelor's degree in a scientific or health-related field. At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting. Oncology trial experience is highly preferred; early-phase development experience is beneficial. Knowledge of FDA regulations and ICH/GCP guidelines is essential. Strong organizational and multitasking skills, with the ability to work in a collaborative team environment. Excellent written and verbal communication skills. Problem-solving and negotiation abilities, with the ability to adapt as needed. Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).
US$200000 - US$230000 per year
San Diego
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Snr Director Statistical Programming
We have a current opportunity for a Snr Director Statistical Programming on a permanent basis. The position will be based in California or Massachusetts. For further information about this position please apply. Job Title: Senior Director of Statistical Programming Salary: $230,000-$260,000 base Position Overview: We are seeking an experienced and highly motivated Senior Director of Statistical Programming to lead our statistical programming team. This role is critical to our clinical development efforts and will involve overseeing the design, development, and implementation of statistical programming activities for our clinical trials. Key Responsibilities: Lead and manage the statistical programming team, providing mentorship and guidance to junior programmers. Oversee the development, validation, and maintenance of SAS programs to support clinical trial data analysis and reporting. Collaborate with biostatisticians, data managers, and clinical teams to ensure the accuracy and integrity of clinical trial data. Develop and implement standard operating procedures (SOPs) for statistical programming activities. Ensure compliance with regulatory requirements and industry standards (e.g., CDISC, FDA, EMA). Participate in the preparation of statistical analysis plans (SAPs) and clinical study reports (CSRs). Provide strategic input on statistical programming aspects of clinical development plans. Stay current with industry trends and advancements in statistical programming methodologies. Qualifications: Advanced degree (Master's or Ph.D.) in Statistics, Mathematics, Biostatistics, Computer Science, or a related field. Minimum of 14 years of experience in statistical programming within the biotech or pharmaceutical industry. Proven leadership experience with a track record of managing and developing high-performing teams. Expertise in SAS programming and familiarity with other statistical software (e.g., R, Python) is a plus. Early and late stage clinical trial experience Regulatory interraction experience Strong knowledge of clinical trial design, data management, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. What We Offer: Competitive salary and benefits package. Opportunity to work in a fast-paced, innovative environment. Career growth and development opportunities. A supportive and inclusive company culture.
US$230000 - US$260000 per year
United States of America
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AD Statistical Programming - R
We have a current opportunity for a Sr Manager/AD Statistical Programming - R on a permanent basis. The position will be based in Massachusetts or Illinois. For further information about this position please apply. Job Title: Sr Manager/Associate Director, Statistical Programming Job Type: Full-Time We're a dynamic and innovative pharmaceutical company dedicated to improving patient outcomes through cutting-edge research and development. We are committed to fostering a collaborative and inclusive work environment where every team member can thrive. Job Summary: We are seeking a highly skilled and motivated Sr Manager/Associate Director of Statistical Programming with extensive experience in R and SAS to join our growing team. The successful candidate will lead and oversee statistical programming activities for clinical trials, ensuring the highest standards of data integrity and analysis. Key Responsibilities: Lead and manage a team of statistical programmers, providing mentorship and guidance. Develop and implement statistical programming strategies and plans for clinical trials. Collaborate with biostatisticians, data managers, and clinical teams to ensure accurate and timely delivery of statistical outputs. Create, validate, and maintain complex statistical programs using R and SAS. Ensure compliance with regulatory requirements and industry standards. Review and approve programming deliverables, including datasets, tables, listings, and figures (TLFs). Participate in the development of standard operating procedures (SOPs) and best practices. Provide technical expertise and support for ad-hoc analyses and data requests. Drive strategy and resourcing in conjunction with departmental needs and initiatives Stay current with industry trends and advancements in statistical programming and R and SAS. Qualifications: Master's in Statistics, Biostatistics, Computer Science, or a related field. Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry. Proficiency in R programming and SAS is required. Strong understanding of clinical trial design, data management, and regulatory requirements. Excellent leadership and team management skills. Strong problem-solving abilities and attention to detail. Effective communication and interpersonal skills. Ability to work collaboratively in a fast-paced, dynamic environment. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Generous paid time off and holiday schedule. Professional development opportunities. Collaborative and inclusive work culture.
US$170000 - US$210000 per year
Massachusetts
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Manager/AD Standards Statistical Programming
We have a current opportunity for a Manager/AD Standards Statistical Programming Role on a permanent basis. For further information about this position please apply and let's have an open discussion. Job Title: Manager/Associate Director, Statistical Programming Standards Job Type: Full-Time Department: Biostatistics and Programming Job Summary: We are seeking an experienced Manager/Associate Director of Statistical Standards Programming to join our dynamic team. The successful candidate will be responsible for developing and maintaining programming standards, ensuring compliance with regulatory requirements, and providing expertise in R and SAS programming. This role will involve collaboration with cross-functional teams to support clinical trials and other research activities. Key Responsibilities: Develop, implement, and maintain statistical programming standards and guidelines. Ensure compliance with regulatory requirements and industry best practices. Provide expertise in both R and SAS programming to support clinical trial data analysis and reporting. Collaborate with biostatisticians, data managers, and other stakeholders to ensure the quality and consistency of statistical programming deliverables. Lead the development and maintenance of standard macros, templates, and tools to improve efficiency and quality. Provide technical leadership for statistical standards Accountable for utilizing statistical methods for data analysis, providng R Packaging Review and approve programming deliverables to ensure adherence to standards. Stay current with industry trends and advancements in statistical programming and regulatory requirements. Qualifications: Bachelor's or Master's degree in Statistics, Computer Science, or a related field. Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry. Clinical trial experience in early/late stages Expertise in both R and SAS programming languages. Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., CDISC). Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Ability to work effectively in a team-oriented environment. Experience with clinical trial data and ICH/CDASH/CDISC standards (SDTM, ADaM, TFL) is highly desirable. Preferred Qualifications: Master's in Statistics, Computer Science, or a related field. Experience in a leadership role within statistical programming. Knowledge in other statistical programming languages/software like Spotfire, WinBUGS, Python, , etc Benefits: Competitive salary and benefits package. Opportunities for professional development and career advancement. Collaborative and inclusive work environment.
US$140000 - US$180000 per year
United States of America
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Director Clinical Data Management
We have a current opportunity for a Director Clinical Data Management on a permanent basis. The position will be based in Massachusetts. For further information about this position please apply. Job Title: Director of Clinical Data Management Location: Massachusetts Company Overview: We're representing a pioneering biopharmaceutical company dedicated to developing innovative therapies for neurological disorders. Our mission is to improve the lives of patients through cutting-edge research and development. Position Summary: We are seeking an experienced and highly motivated Director of Clinical Data Management to lead our data management team. The ideal candidate will have a strong background in clinical data management, particularly in the context of neurological clinical trials. This role will be critical in ensuring the integrity, accuracy, and completeness of clinical trial data, supporting our mission to bring new therapies to patients in need. Key Responsibilities: Lead and manage the Clinical Data Management (CDM) team, providing strategic direction and oversight. Develop and implement data management plans, including data collection, processing, and quality control procedures. Ensure compliance with regulatory requirements and industry standards (e.g., FDA, ICH-GCP). Serve as a subject matter expert for various operations, including, but not limited to, electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes. Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs, to support clinical trial activities. Support vendor UATs for database builds Oversee the selection and management of data management vendors and systems. Monitor data quality and integrity throughout the clinical trial lifecycle. Provide leadership in the development and maintenance of standard operating procedures (SOPs) related to data management. Participate in the preparation of clinical study reports and regulatory submissions. Stay current with industry trends and advancements in clinical data management technologies and methodologies. Qualifications: Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, Data Management); advanced degree preferred. Minimum of 10 years of experience in clinical data management, with at least 3 years in a leadership role. Experience in neurological or rare disease clinical trials is highly desirable. Proficient in clinical data collection/reporting/review and analysis processes using EDC platforms (i.e., Medidata, Veeva, ePRO, etc.) for Phase I-IV clinical trials in pharmaceutical industry Strong knowledge of clinical trial processes, regulatory requirements, and data management best practices. Proficiency with clinical data management systems (e.g., EDC, CDMS) and software (e.g., SAS, SQL). Excellent leadership, communication, and interpersonal skills. Knowledge of industry and regulatory standards (FDA and EMEA Regulations, ICH Guidelines, and GCP) including CDISC standards (CDASH/SDTM). Ability to work effectively in a fast-paced, collaborative environment. Strong problem-solving and analytical skills. Benefits: Competitive salary and benefits package. Opportunity to work with a passionate and dedicated team. Chance to make a significant impact on the development of therapies for neurological disorders. Professional development and growth opportunities.
US$220000 - US$250000 per year
Massachusetts
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AD Statistics Late Stage oncology
We have a current opportunity for a AD Statistics Late Stage oncology on a permanent basis. The position will be based in NJ or can be remote. For further information about this position please apply. Job Title: Associate Director, Statistics - Late Stage Oncology Position Overview: We are seeking a highly skilled and motivated Associate Director of Statistics to join our Late Stage Oncology team. The successful candidate will play a critical role in the design, analysis, and interpretation of clinical trials, ensuring the highest standards of statistical rigor and scientific integrity. Key Responsibilities: Lead the statistical strategy for late-stage oncology clinical trials Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to develop and execute clinical trial protocols. Provide statistical expertise in the design of clinical trials, including sample size calculations, randomization schemes, and statistical analysis plans. Analyze clinical trial data and interpret results, ensuring accurate and comprehensive reporting. Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications. Ensure compliance with regulatory guidelines and industry standards for statistical practices. Mentor and provide guidance to junior statisticians and other team members. Stay current with advancements in statistical methodologies and oncology research. Qualifications: Ph.D. or M.S. in Statistics, Biostatistics, or a related field. Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with a focus on oncology. Proven track record of leading statistical aspects of late-stage clinical trials. Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA). Proficiency in statistical software (e.g., SAS, R). Excellent communication and interpersonal skills. Ability to work effectively in a collaborative, fast-paced environment. Preferred Qualifications: Experience with adaptive trial designs and Bayesian statistics. Publications in peer-reviewed journals. Experience in interactions with regulatory agencies. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Opportunities for professional development and career advancement. Collaborative and inclusive work environment.
US$180000 - US$210000 per year
Basking Ridge
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Manager/AD Standards Statistical Programming
We have a current opportunity for a Manager/AD Standards Statistical Programming Role on a permanent basis. For further information about this position please apply and let's have an open discussion. Job Title: Manager/Associate Director, Statistical Programming Standards Job Type: Full-Time Department: Biostatistics and Programming Job Summary: We are seeking an experienced Manager/Associate Director of Statistical Standards Programming to join our dynamic team. The successful candidate will be responsible for developing and maintaining programming standards, ensuring compliance with regulatory requirements, and providing expertise in R and SAS programming. This role will involve collaboration with cross-functional teams to support clinical trials and other research activities. Key Responsibilities: Develop, implement, and maintain statistical programming standards and guidelines. Ensure compliance with regulatory requirements and industry best practices. Provide expertise in both R and SAS programming to support clinical trial data analysis and reporting. Collaborate with biostatisticians, data managers, and other stakeholders to ensure the quality and consistency of statistical programming deliverables. Lead the development and maintenance of standard macros, templates, and tools to improve efficiency and quality. Provide technical leadership for statistical standards Accountable for utilizing statistical methods for data analysis, providng R Packaging Review and approve programming deliverables to ensure adherence to standards. Stay current with industry trends and advancements in statistical programming and regulatory requirements. Qualifications: Bachelor's or Master's degree in Statistics, Computer Science, or a related field. Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry. Clinical trial experience in early/late stages Expertise in both R and SAS programming languages. Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., CDISC). Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills. Ability to work effectively in a team-oriented environment. Experience with clinical trial data and ICH/CDASH/CDISC standards (SDTM, ADaM, TFL) is highly desirable. Preferred Qualifications: Master's in Statistics, Computer Science, or a related field. Experience in a leadership role within statistical programming. Knowledge in other statistical programming languages/software like Spotfire, WinBUGS, Python, , etc Benefits: Competitive salary and benefits package. Opportunities for professional development and career advancement. Collaborative and inclusive work environment.
US$140000 - US$180000 per year
United States of America
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Snr Director Statistical Programming
We have a current opportunity for a Snr Director Statistical Programming on a permanent basis. The position will be based in California or Massachusetts. For further information about this position please apply. Job Title: Senior Director of Statistical Programming Salary: $230,000-$260,000 base Position Overview: We are seeking an experienced and highly motivated Senior Director of Statistical Programming to lead our statistical programming team. This role is critical to our clinical development efforts and will involve overseeing the design, development, and implementation of statistical programming activities for our clinical trials. Key Responsibilities: Lead and manage the statistical programming team, providing mentorship and guidance to junior programmers. Oversee the development, validation, and maintenance of SAS programs to support clinical trial data analysis and reporting. Collaborate with biostatisticians, data managers, and clinical teams to ensure the accuracy and integrity of clinical trial data. Develop and implement standard operating procedures (SOPs) for statistical programming activities. Ensure compliance with regulatory requirements and industry standards (e.g., CDISC, FDA, EMA). Participate in the preparation of statistical analysis plans (SAPs) and clinical study reports (CSRs). Provide strategic input on statistical programming aspects of clinical development plans. Stay current with industry trends and advancements in statistical programming methodologies. Qualifications: Advanced degree (Master's or Ph.D.) in Statistics, Mathematics, Biostatistics, Computer Science, or a related field. Minimum of 14 years of experience in statistical programming within the biotech or pharmaceutical industry. Proven leadership experience with a track record of managing and developing high-performing teams. Expertise in SAS programming and familiarity with other statistical software (e.g., R, Python) is a plus. Early and late stage clinical trial experience Regulatory interraction experience Strong knowledge of clinical trial design, data management, and regulatory requirements. Excellent problem-solving skills and attention to detail. Strong communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. What We Offer: Competitive salary and benefits package. Opportunity to work in a fast-paced, innovative environment. Career growth and development opportunities. A supportive and inclusive company culture.
US$230000 - US$260000 per year
Massachusetts
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AD Statistics Late Stage oncology
We have a current opportunity for a AD Statistics Late Stage oncology on a permanent basis. The position will be based in NJ or can be remote. For further information about this position please apply. Job Title: Associate Director, Statistics - Late Stage Oncology Position Overview: We are seeking a highly skilled and motivated Associate Director of Statistics to join our Late Stage Oncology team. The successful candidate will play a critical role in the design, analysis, and interpretation of clinical trials, ensuring the highest standards of statistical rigor and scientific integrity. Key Responsibilities: Lead the statistical strategy for late-stage oncology clinical trials Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to develop and execute clinical trial protocols. Provide statistical expertise in the design of clinical trials, including sample size calculations, randomization schemes, and statistical analysis plans. Analyze clinical trial data and interpret results, ensuring accurate and comprehensive reporting. Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications. Ensure compliance with regulatory guidelines and industry standards for statistical practices. Mentor and provide guidance to junior statisticians and other team members. Stay current with advancements in statistical methodologies and oncology research. Qualifications: Ph.D. or M.S. in Statistics, Biostatistics, or a related field. Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with a focus on oncology. Proven track record of leading statistical aspects of late-stage clinical trials. Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA). Proficiency in statistical software (e.g., SAS, R). Excellent communication and interpersonal skills. Ability to work effectively in a collaborative, fast-paced environment. Preferred Qualifications: Experience with adaptive trial designs and Bayesian statistics. Publications in peer-reviewed journals. Experience in interactions with regulatory agencies. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Opportunities for professional development and career advancement. Collaborative and inclusive work environment.
US$180000 - US$210000 per year
Basking Ridge
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