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Associate Director Biostatistics
150726
Posted:
24th
September 2024
- 190000 USD - 190000 USD
- South San Francisco, United States
- Permanent
We are seeking an Associate Director of Biostatistics to lead statistical analysis and interpretation of clinical trial data. This role involves serving as the statistical lead on several Phase 2 and 3 clinical trials, developing statistical analysis plans and mock TLFs (tables, listings, and figures), reviewing clinical study data, regulatory documents, and supporting topline readouts and regulatory filings. The successful candidate will collaborate closely with all Biometrics functions, ensuring the quality of study data and the accuracy of statistical outputs. Oversight of CROs may be required, and some independent programming work will be needed for quality control and ad-hoc analyses. Experience in simulation work and multiple imputation analyses is preferred. This position reports to the Director of Biostatistics.
Responsibilities
- Apply statistical methods to the analysis and interpretation of clinical trial data.
- Represent the Biometrics function cross-functionally at the study team level and in other working groups.
- Provide statistical input in the evaluation, interpretation, and preparation of study results.
- Develop statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations, and more.
- Supervise CROs and perform clinical data review, assisting with the resolution of any queries that arise during the data management and statistical analysis process.
- Provide ad-hoc data listings and summary information as requested.
- Perform quality control on data and programs used for analysis, ensuring the validity of key efficacy and safety endpoints.
- Improve quality processes to meet the growing demand for data and output validation.
- Manage and support the preparation of data packages for NDA and other regulatory submissions.
- Mentor junior team members or contractors as needed, while primarily acting as an individual contributor.
The Ideal Candidate
- Ph.D. in Biostatistics or equivalent, with a minimum of 6 years of experience (or Master’s degree with at least 8 years of experience) in statistical analysis and programming support in the biotech/pharmaceutical industry.
- Experience with late-phase clinical trials is desired.
- Comprehensive knowledge of statistical experimental design, analysis, and clinical trial requirements. Experience in simulation work and multiple imputation analyses is a plus.
- Proficiency with statistical software such as R and SAS.
- Ability to work in a regulated environment and adhere to company SOPs and procedures.
- Strong organizational skills, with the ability to manage workflows and activities to meet department timelines.
- Ability to manage deliverables with competing priorities and influence others effectively.
- Excellent critical thinking, information-seeking, and analytical skills.
- Strong interpersonal and communication skills, both oral and written.
- Thorough attention to detail and consistency.
Education
- Ph.D. in Biostatistics or equivalent, with a minimum of 6 years of experience (or a Master’s degree with at least 8 years of experience).
This position is located in South San Francisco, CA. At this time we are not considering remote applicants.
Martin Wenzel
Division Director