Manager Clinical Data Management
We have a current opportunity for a Manager CDM on a permanent basis. The position will be based in Cambridge, Massachusetts. For further information about this position please apply. Job Title: Manager, Clinical Data Management Location: Massachusetts, USA | onsite position Job Type: Full-time Job Summary: We are seeking an experienced and detail-oriented Manager of Clinical Data Management to join our team. The successful candidate will oversee the data management activities for clinical trials, ensuring the integrity, accuracy, and security of clinical data. This role requires strong leadership skills, a deep understanding of clinical data management processes, and the ability to work collaboratively with cross-functional teams. Key Responsibilities: Design and Implement Data Collection Systems: Develop and maintain efficient systems and tools for clinical data collection, ensuring compliance with regulatory standards. Data Management Oversight: Supervise the data management process, including data collection, entry, verification, and cleaning to ensure high-quality data. Regulatory Compliance: Ensure all data management activities comply with Good Clinical Practice (GCP) and other relevant regulatory guidelines. Collaboration: Work closely with investigators, biostatisticians, and other healthcare professionals to gather, interpret, and analyze clinical data. Documentation: Prepare and maintain comprehensive documentation, including data management plans, standard operating procedures (SOPs), and clinical study reports. Team Leadership: Train, mentor, and supervise data management staff, fostering a collaborative and productive work environment. Problem-Solving: Address and resolve data queries and discrepancies, ensuring data consistency and accuracy. Project Management: Manage timelines and deliverables for data management activities, ensuring project deadlines are met. Qualifications: Education: Bachelor's degree in Life Sciences, Computer Science, or a related field. Advanced degree preferred. Experience: Minimum of 10 years of experience in clinical data management, with at least 2 years in a supervisory or managerial role within a CRO or pharmaceutical environment. Technical Skills: Proficiency in clinical data management systems (e.g., EDC systems), database management, and statistical software. Regulatory Knowledge: In-depth knowledge of GCP, FDA, and other regulatory requirements. Soft Skills: Excellent communication, leadership, and problem-solving skills. Ability to work effectively in a team-oriented environment.
US$140000 - US$160000 per year
Massachusetts
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Manager Clinical Data Management
We have a current opportunity for a Manager CDM on a permanent basis. The position will be based in Cambridge, Massachusetts. For further information about this position please apply. Job Title: Manager, Clinical Data Management Location: Massachusetts, USA | onsite position Job Type: Full-time Job Summary: We are seeking an experienced and detail-oriented Manager of Clinical Data Management to join our team. The successful candidate will oversee the data management activities for clinical trials, ensuring the integrity, accuracy, and security of clinical data. This role requires strong leadership skills, a deep understanding of clinical data management processes, and the ability to work collaboratively with cross-functional teams. Key Responsibilities: Design and Implement Data Collection Systems: Develop and maintain efficient systems and tools for clinical data collection, ensuring compliance with regulatory standards. Data Management Oversight: Supervise the data management process, including data collection, entry, verification, and cleaning to ensure high-quality data. Regulatory Compliance: Ensure all data management activities comply with Good Clinical Practice (GCP) and other relevant regulatory guidelines. Collaboration: Work closely with investigators, biostatisticians, and other healthcare professionals to gather, interpret, and analyze clinical data. Documentation: Prepare and maintain comprehensive documentation, including data management plans, standard operating procedures (SOPs), and clinical study reports. Team Leadership: Train, mentor, and supervise data management staff, fostering a collaborative and productive work environment. Problem-Solving: Address and resolve data queries and discrepancies, ensuring data consistency and accuracy. Project Management: Manage timelines and deliverables for data management activities, ensuring project deadlines are met. Qualifications: Education: Bachelor's degree in Life Sciences, Computer Science, or a related field. Advanced degree preferred. Experience: Minimum of 10 years of experience in clinical data management, with at least 2 years in a supervisory or managerial role within a CRO or pharmaceutical environment. Technical Skills: Proficiency in clinical data management systems (e.g., EDC systems), database management, and statistical software. Regulatory Knowledge: In-depth knowledge of GCP, FDA, and other regulatory requirements. Soft Skills: Excellent communication, leadership, and problem-solving skills. Ability to work effectively in a team-oriented environment.
US$140000 - US$160000 per year
Massachusetts
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AD Biostatistics
We have a current opportunity for a AD Biostatistics on a permanent basis. The site location is in New Jersey. This position can be remote or hybrid on site. We're seeking talented Biostatisticians that have pharma industry experience in Oncology early/late phase. For further information about this position please apply. Job Title: Associate Director, Biostatistics Location: New Jersey Company Overview: We are a mid-sized oncology pharmaceutical company dedicated to developing innovative cancer therapies. Our mission is to improve patient outcomes and quality of life through cutting-edge research and development. Position Overview: The Associate Director of Biostatistics will provide strategic and statistical leadership for our late stage oncology clinical development programs. This role involves designing and analyzing clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to support the development of new cancer treatments. Key Responsibilities: Provide statistical leadership and support for oncology clinical trials, including study design, statistical analysis plans, and data interpretation. Collaborate with clinical teams to develop case report forms and ensure accurate data collection. Conduct statistical analyses and provide input for clinical study reports, scientific presentations, and manuscripts. Lead discussions with regulatory authorities and serve as a statistical responder in FDA advisory committee meetings. Develop and implement statistical standard operating procedures (SOPs) and contribute to process improvements. Mentor and develop junior biostatisticians and other team members. Stay current with advancements in biostatistics and oncology research to ensure the application of best practices. Qualifications: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. Minimum of 8 years of experience in biostatistics, with at least 5 years in the pharmaceutical or biotechnology industry. Strong knowledge of statistical methods and their application in clinical trials. Experience with regulatory submissions and interactions with health authorities. Proficiency in statistical software (e.g., SAS, R). Excellent communication and leadership skills. Ability to work collaboratively in a cross-functional team environment. Preferred Qualifications: Experience in oncology clinical trials. Familiarity with FDA and EMA guidelines for drug development. Demonstrated ability to lead and manage multiple projects simultaneously. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. 401(k) with company match. Professional development opportunities. Flexible work arrangements.
US$180000 - US$210000 per year
New Jersey
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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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Manager, Biostatistics
Title: Manager, Biostatistics Location: Boston (Fully Onsite - 5 days a Week) I am seeking to connect with experienced and highly motivated Manager, Biostatistics Leaders. This will play a critical role in leading the biostatistics team in the design, analysis, and interpretation of clinical trial data. The ideal candidate will have strong statistical expertise, excellent leadership skills, and a proven track record of successful collaboration with cross-functional teams. Key Responsibilities: Team Leadership: Supervise and mentor a team of biostatisticians Project Management: Oversee project budgets, forecast resource needs, and ensure timely delivery of statistical outputs. Client Interaction: Participate in client meetings, presentations, budgets and proposels, and bid defenses, Statistical Expertise: Provide statistical input for protocol development, study design, and CRF creation. Perform sample size calculations and draft statistical methodology sections. Experience: Master's or Ph.D. in Biostatistics, Statistics, or a related field. Minimum of 8 years of experience in the biostatistics field, with at least 2 years in a managerial or leadership role. Strong understanding of clinical trial design, statistical analysis, and regulatory requirements. Experience with statistical software (e.g., SAS, R, or other statistical tools).
US$150000 - US$175000 per year
Cambridge
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Manager Clinical Data Management
We have a current opportunity for a Manager CDM on a permanent basis. The position will be based in Cambridge, Massachusetts. For further information about this position please apply. Job Title: Manager, Clinical Data Management Location: Massachusetts, USA | onsite position Job Type: Full-time Job Summary: We are seeking an experienced and detail-oriented Manager of Clinical Data Management to join our team. The successful candidate will oversee the data management activities for clinical trials, ensuring the integrity, accuracy, and security of clinical data. This role requires strong leadership skills, a deep understanding of clinical data management processes, and the ability to work collaboratively with cross-functional teams. Key Responsibilities: Design and Implement Data Collection Systems: Develop and maintain efficient systems and tools for clinical data collection, ensuring compliance with regulatory standards. Data Management Oversight: Supervise the data management process, including data collection, entry, verification, and cleaning to ensure high-quality data. Regulatory Compliance: Ensure all data management activities comply with Good Clinical Practice (GCP) and other relevant regulatory guidelines. Collaboration: Work closely with investigators, biostatisticians, and other healthcare professionals to gather, interpret, and analyze clinical data. Documentation: Prepare and maintain comprehensive documentation, including data management plans, standard operating procedures (SOPs), and clinical study reports. Team Leadership: Train, mentor, and supervise data management staff, fostering a collaborative and productive work environment. Problem-Solving: Address and resolve data queries and discrepancies, ensuring data consistency and accuracy. Project Management: Manage timelines and deliverables for data management activities, ensuring project deadlines are met. Qualifications: Education: Bachelor's degree in Life Sciences, Computer Science, or a related field. Advanced degree preferred. Experience: Minimum of 10 years of experience in clinical data management, with at least 2 years in a supervisory or managerial role within a CRO or pharmaceutical environment. Technical Skills: Proficiency in clinical data management systems (e.g., EDC systems), database management, and statistical software. Regulatory Knowledge: In-depth knowledge of GCP, FDA, and other regulatory requirements. Soft Skills: Excellent communication, leadership, and problem-solving skills. Ability to work effectively in a team-oriented environment.
US$140000 - US$160000 per year
Massachusetts
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AD Biostatistics
We have a current opportunity for a AD Biostatistics on a permanent basis. The site location is in New Jersey. This position can be remote or hybrid on site. We're seeking talented Biostatisticians that have pharma industry experience in Oncology early/late phase. For further information about this position please apply. Job Title: Associate Director, Biostatistics Location: New Jersey Company Overview: We are a mid-sized oncology pharmaceutical company dedicated to developing innovative cancer therapies. Our mission is to improve patient outcomes and quality of life through cutting-edge research and development. Position Overview: The Associate Director of Biostatistics will provide strategic and statistical leadership for our late stage oncology clinical development programs. This role involves designing and analyzing clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to support the development of new cancer treatments. Key Responsibilities: Provide statistical leadership and support for oncology clinical trials, including study design, statistical analysis plans, and data interpretation. Collaborate with clinical teams to develop case report forms and ensure accurate data collection. Conduct statistical analyses and provide input for clinical study reports, scientific presentations, and manuscripts. Lead discussions with regulatory authorities and serve as a statistical responder in FDA advisory committee meetings. Develop and implement statistical standard operating procedures (SOPs) and contribute to process improvements. Mentor and develop junior biostatisticians and other team members. Stay current with advancements in biostatistics and oncology research to ensure the application of best practices. Qualifications: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. Minimum of 8 years of experience in biostatistics, with at least 5 years in the pharmaceutical or biotechnology industry. Strong knowledge of statistical methods and their application in clinical trials. Experience with regulatory submissions and interactions with health authorities. Proficiency in statistical software (e.g., SAS, R). Excellent communication and leadership skills. Ability to work collaboratively in a cross-functional team environment. Preferred Qualifications: Experience in oncology clinical trials. Familiarity with FDA and EMA guidelines for drug development. Demonstrated ability to lead and manage multiple projects simultaneously. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. 401(k) with company match. Professional development opportunities. Flexible work arrangements.
US$180000 - US$210000 per year
New Jersey
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Associate Director / Director, Biostatistics
Job Title: Associte Director / Director, Biostatistics Leading Pharma Job Summary: A leading pharmaceutical company in Indiana, is seeking a highly skilled and strategic Biostatistics Leaders to join their team! Responsibilities - Ensure appropriate statistical methodology is applied across all phases of clinical trials, including innovative methods such as adaptive designs, Bayesian approaches, and complex statistical modeling. Oversee the statistical analysis and interpretation of clinical trial data, ensuring the highest standards of quality and regulatory compliance. Ensure continuous improvement of statistical processes, methods, and tools used by the biostatistics team. Qualifications: Ph.D. or M.S. in statistics, biostatistics, or a related field. Minimum of 5 years of experience in biostatistics (Minimium of 7 for Director) Experience in the pharmaceutical or biotechnology industry. Experience with regulatory submissions and compliance. Familiarity with statistical software and programming languages (e.g., SAS, R).
US$170000 - US$225000 per year
Indiana
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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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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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Principal Biostatistician
We have a current opportunity for a Principal Biostatistician on a permanent basis. The position will be remote. For further information about this position please apply. Job Title: Principal Biostatistician Location: Remote Job Type: Full-Time About Us: We're partnered with a leading Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharamceutical industry. Job Summary: We are seeking a highly skilled and experienced Principal Biostatistician to join our dynamic team. The Principal Biostatistician will play a critical role in the design, analysis, and interpretation of clinical trials, ensuring the integrity and accuracy of statistical data. This position requires a deep understanding of biostatistics, clinical trial methodology, and regulatory requirements. Key Responsibilities: Lead the statistical design and analysis of clinical trials, including the development of statistical analysis plans (SAPs). Provide expert statistical consultation to project teams, clients, and regulatory agencies. Ensure the accuracy and integrity of statistical data and results. Collaborate with cross-functional teams, including clinical operations, data management, and medical writing. Develop and validate statistical models and methodologies. Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications. Stay current with industry trends, regulatory guidelines, and best practices in biostatistics. Mentor and train junior biostatisticians and other team members. Qualifications: Ph.D. or Master's degree in Biostatistics or Statistics Minimum of 5 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry. Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements (e.g., ICH, FDA, EMA). Proficiency in statistical software (e.g., SAS, R). Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Experience with regulatory submissions and interactions with regulatory agencies is a plus. Benefits: Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and supportive work environment.
US$140000 - US$170000 per year
New Jersey
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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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