Associate Director, Biostatistics

Role Summary

The Associate Director, Biostatistics will work closely with the Biometrics Team in providing statistical support to clinical studies, commercial or development programs. This role oversees statistical aspects of assigned studies or projects to ensure that scientific, regulatory, quality, and commercial requirements are met and that plans are aligned with development goals. The incumbent will provide statistical knowledge in study design, statistical analysis, reporting, and interpretation of data. This role will provide hands-on support to project teams by conducting statistical analysis, overseeing external vendors, and working closely with programming and data management to plan, organize, coordinate, review, and ensure timeliness and quality of Biometrics deliverables for assigned studies/projects. The incumbent will collaborate with cross-functional teams composed of internal and/or external experts and could also serve as the Biometrics team lead for a project.

Responsibilities

• Represent the statistics function and provide statistical leadership in support of clinical studies or projects, including post-approval studies.
• Contribute to the planning and lead the delivery of the statistical components to support the analysis and reporting needs of clinical studies/projects. Work directly with study/project teams to identify statistical issues, and to propose and implement solutions.
• Conduct ad hoc and exploratory analyses to support Medical Affairs and commercial needs, including review of abstracts and manuscripts for publications and presentations
• Provide statistical input to study reports, regulatory documents, publications, and other internal or external data requests. Perform statistical modeling and analyses as needed.
• Prepare, review and/or approve SAPs, case report forms, clinical DB specifications, validation plans, TFLs, reporting and analysis datasets specifications, and supporting documentation.
• Provide statistical oversight to internal and/or external Biometrics teams to ensure timeliness and quality of study/project deliverables.
• Contribute to the development and maintenance of Biometrics-related SOPs, work practice documents, technical standards, and specification documents.
• Research and apply new statistical approaches as needed. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.

Education/Experience Requirements

• M.S. in Statistics/Biostatistics is required, Ph.D. is preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 6 years of relevant experience in the biopharmaceutical industry.
• Hands-on experience in all tasks of a Study Statistician (at least 4 years) or Lead Statistician (at least 2 years). Experience with late-stage drug development, regulatory submissions, registries, or Health Authority interactions is a plus.
• Experience with study design and program planning.

Additional Skills/Experience/Requirements

• Vendor oversight experience.
• Knowledge of the drug development process, from early to late stage. Experience in orphan or rare diseases is a plus.
• Understanding of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory submissions.
• Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations.
• Proficiency in SAS programming to produce ad hoc tables, listings and figures. Experience with other statistical software such as R preferred.
• Experience with data pooling to support Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) and periodic reports.
• Experience working with Medical Affairs to develop abstracts and perform appropriate analyses suitable for publication.
• Ability to manage multiple tasks with competing timelines.
• Excellent communication and collaboration skills. Ability to explain statistical concepts to non-statisticians.
• Solution oriented, attention to detail, interest and ability to perform in a high-demand and dynamic working environment.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
• Able to travel as needed (10%-15%).