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/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 of Biostatistics
Position Summary: The Director of Biostatistics will play a critical role in the design, analysis, and interpretation of clinical trials. This individual will provide strategic leadership and expertise in biostatistics to support our Phase III clinical programs. The ideal candidate will have a strong background in biostatistics, experience in CNS clinical trials, and a passion for innovative research. Key Responsibilities: Lead the biostatistics function for Phase III clinical trials, ensuring robust statistical design and analysis. Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to develop and execute statistical analysis plans. Provide statistical input into clinical trial protocols, study design, and regulatory submissions. Oversee the preparation of statistical sections of clinical study reports, regulatory documents, and publications. Ensure compliance with regulatory guidelines and industry standards for statistical practices. Mentor and develop junior biostatisticians, fostering a culture of continuous learning and innovation. Stay current with advancements in biostatistics and clinical trial methodologies, applying best practices to our research programs. Qualifications: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. Minimum of 10 years of experience in biostatistics, with a focus on CNS clinical trials. Proven track record of leading biostatistics efforts for Phase III clinical trials. Strong knowledge of regulatory requirements and guidelines for clinical trials. Excellent communication and leadership skills, with the ability to work effectively in a collaborative team environment. Proficiency in statistical software (e.g., SAS, R) and clinical trial data management systems.
US$220000 - US$230000 per year
Pennsylvania
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Sr. Director of Clinical Data Management
Sr. Director Clinical Data Management San Diego, CA - Hybrid 198,000-286,000 A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. 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 Director of Clinical Data Management Responsibilities will include: Leading clinical data management oversight of clinical trials, including project management, CRO management, coordination of internal reviews, and approval of routine data management deliverables. Setting up data management vendors as required, including the review of RFPs, evaluating, and negotiating data management budgets and contracts. Leading the development and review of all Clinical Data Management-related documents, including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plans, etc. Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity. Providing direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones. Overseeing database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standards and regulatory requirements. Being responsible for sponsor user acceptance testing, including documenting findings and resolving issues with CRO. Overseeing data management activities, including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding, and driving data snapshot/closeout activities. Proactively identifying risks and executing risk mitigation strategies; maintaining timely communication with both upper management and cross-functional teams. Supervising CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to. Contributing to program deliverable timeline creation and project re-forecasting. Supporting data management activities for regulatory submissions. Leading the development of CDM-related Standard Operating Procedures (SOPs) and Work Instructions. Performing additional duties as assigned. Qualifications Bachelor's degree mandatory, with a minimum of 6years hands-on data management experience in the CRO, biotech, or pharmaceutical sector. Oncology experience required. Strong vendor management skills
US$198000 - US$286000 per year
San Diego
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Director, Clinical Data Management
Job Title: Director, Clinical Data Management (CDM) Location: New York Job Summary: The Director of Clinical Data Management (CDM) will assist with leading the CDM team in the design, implementation, and management of clinical data systems and processes. This role is responsible for ensuring the accuracy, integrity, and security of clinical trial data. Key Responsibilities: Develop and implement data management strategies and processes for clinical trials. Ensure the accuracy, integrity, and security of clinical trial data. Oversee the development and execution of data management plans, including data collection, cleaning, and validation. Ensure compliance with regulatory requirements and industry standards (e.g., FDA, ICH-GCP). Qualifications: Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred. Minimum of 8 years of experience in clinical data management Strong knowledge of clinical trial processes and regulatory requirements. Excellent leadership, communication, and interpersonal skills. Strong problem-solving skills. Preferred Qualifications: Knowledge of programming languages (e.g., SAS, SQL).
US$170000 - US$180000 per year
New York
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Director, Clinical Data Management
Job Title: Director, Clinical Data Management (CDM) Location: New York Job Summary: The Director of Clinical Data Management (CDM) will assist with leading the CDM team in the design, implementation, and management of clinical data systems and processes. This role is responsible for ensuring the accuracy, integrity, and security of clinical trial data. Key Responsibilities: Develop and implement data management strategies and processes for clinical trials. Ensure the accuracy, integrity, and security of clinical trial data. Oversee the development and execution of data management plans, including data collection, cleaning, and validation. Ensure compliance with regulatory requirements and industry standards (e.g., FDA, ICH-GCP). Qualifications: Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred. Minimum of 8 years of experience in clinical data management Strong knowledge of clinical trial processes and regulatory requirements. Excellent leadership, communication, and interpersonal skills. Strong problem-solving skills. Preferred Qualifications: Knowledge of programming languages (e.g., SAS, SQL).
US$170000 - US$180000 per year
New York
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AD Statistics Late Stage Oncology
Job Title: Associate Director, Biostatistics Late Stage (Oncology) Salary: $180k-220k base + bonus + benefits Job Summary: The Associate Director of Biostatistics in Oncology will provide strategic and technical leadership in the design, analysis, and interpretation of clinical trials in oncology. This role will collaborate with cross-functional teams to ensure the statistical integrity and scientific validity of clinical studies. The Associate Director will also contribute to regulatory submissions and the development of innovative statistical methodologies. Key Responsibilities: Lead the statistical design and analysis of oncology clinical trials, ensuring robust and scientifically sound methodologies. Collaborate with clinical development, regulatory affairs, and other departments to develop clinical trial protocols and statistical analysis plans. Provide statistical expertise for regulatory submissions, including preparation of statistical sections of INDs, NDAs, and other regulatory documents. Oversee the development and validation of statistical models and methodologies for oncology studies. Ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs). Review and approve statistical deliverables, including analysis datasets, tables, listings, and figures. Participate in the selection and management of biostatistics vendors and contractors. Stay current with advancements in statistical methodologies with oncology late stage research, incorporating new techniques as appropriate. Present statistical findings to internal and external stakeholders, including regulatory agencies and scientific conferences. Qualifications: Ph.D. or Master's degree in biostatistics, statistics, or a related field. Minimum of 5 years of experience in biostatistics, with at least 3 years in a Study/Project leadership role within oncology late stage expertise. Vendor Management Oversight experience Strong knowledge of clinical trial design, statistical analysis, and regulatory requirements in oncology. Proficiency in statistical software (e.g., SAS, R) Excellent organizational, communication, and leadership skills. Ability to work collaboratively in a fast-paced, dynamic environment. Detail-oriented with strong problem-solving and analytical skills. Preferred Qualifications: Experience with global clinical trials and regulatory submissions (FDA, EMA) Knowledge of CDISC standards (SDTM, ADaM). Experience with adaptive trial designs and Bayesian methodologies.
US$180000 - US$220000 per year
Basking Ridge
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Sr. Director of Clinical Data Management
Sr. Director Clinical Data Management San Diego, CA - Hybrid 198,000-286,000 A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. 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 Director of Clinical Data Management Responsibilities will include: Leading clinical data management oversight of clinical trials, including project management, CRO management, coordination of internal reviews, and approval of routine data management deliverables. Setting up data management vendors as required, including the review of RFPs, evaluating, and negotiating data management budgets and contracts. Leading the development and review of all Clinical Data Management-related documents, including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plans, etc. Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity. Providing direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones. Overseeing database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standards and regulatory requirements. Being responsible for sponsor user acceptance testing, including documenting findings and resolving issues with CRO. Overseeing data management activities, including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding, and driving data snapshot/closeout activities. Proactively identifying risks and executing risk mitigation strategies; maintaining timely communication with both upper management and cross-functional teams. Supervising CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to. Contributing to program deliverable timeline creation and project re-forecasting. Supporting data management activities for regulatory submissions. Leading the development of CDM-related Standard Operating Procedures (SOPs) and Work Instructions. Performing additional duties as assigned. Qualifications Bachelor's degree mandatory, with a minimum of 6years hands-on data management experience in the CRO, biotech, or pharmaceutical sector. Oncology experience required. Strong vendor management skills
US$198000 - US$286000 per year
San Diego
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Sr. Clinical Data Manager
Sr. Clinical Data Manager San Diego, CA - Hybrid $220,000-$286,000 A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. 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 Director of Clinical Data Management Responsibilities will include: Leading clinical data management oversight of clinical trials, including project management, CRO management, coordination of internal reviews, and approval of routine data management deliverables. Setting up data management vendors as required, including the review of RFPs, evaluating, and negotiating data management budgets and contracts. Leading the development and review of all Clinical Data Management-related documents, including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plans, etc. Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity. Providing direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones. Overseeing database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standards and regulatory requirements. Being responsible for sponsor user acceptance testing, including documenting findings and resolving issues with CRO. Overseeing data management activities, including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding, and driving data snapshot/closeout activities. Proactively identifying risks and executing risk mitigation strategies; maintaining timely communication with both upper management and cross-functional teams. Supervising CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to. Contributing to program deliverable timeline creation and project re-forecasting. Supporting data management activities for regulatory submissions. Leading the development of CDM-related Standard Operating Procedures (SOPs) and Work Instructions. Performing additional duties as assigned. Qualifications Bachelor's degree mandatory, with a minimum of 6years hands-on data management experience in the CRO, biotech, or pharmaceutical sector. Oncology experience required. Strong vendor management skills
US$220000 - US$286000 per year
San Diego
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Senior Biostatistician
Senior Biostatistician We are seeking an experienced and highly skilled Senior Biostatistician to join our client's growing Biostatistics team. In this role, you will play a key part in the design, analysis, and interpretation of clinical trial data across a variety of therapeutic areas. You will work closely with cross-functional teams to ensure high-quality statistical methods are applied to clinical research, contributing to the advancement of innovative medical treatments. Key Responsibilities: Lead the statistical design and analysis of clinical trials, ensuring compliance with regulatory requirements and industry standards. Collaborate with clinical teams to interpret data, provide insights, and support decision-making throughout the trial lifecycle. Develop statistical analysis plans (SAPs) and perform complex statistical analyses using a range of methodologies. Communicate statistical results clearly and effectively to both technical and non-technical stakeholders. Mentor junior statisticians and provide guidance on statistical best practices. Qualifications: PhD in Biostatistics, Statistics, or a related field. Extensive experience in statistical analysis, with a strong background in clinical trials and regulatory submissions. Proficiency in statistical software such as SAS, R, or other relevant tools. Strong communication and collaboration skills, with the ability to work across teams and present findings to diverse audiences.
US$120000 - US$140000 per year
United States of America
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