Associate Director, Biostatistics
LOCATION: San Diego, CA
TYPE: Full Time, Permanent
REPORTS TO: Senior Director, Head of Biometrics
SUMMARY OF RESPONSIBILITIES:
The Associate Director, Biostatistics will be acting as a study-level and program-level statistician. The Associate Director will develop and lead the statistical strategy at study and/or program level. This role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of data management, statistics and programming external vendors.
- Works collaboratively with internal and external clinical research, pharmacologist, programmers, data managers and other clinical, regulatory and project management to meet project deliverables and timelines for statistical data analysis and reporting
- Provides input to statistical issues relating to regulatory submissions. Ensures that all work meets appropriate regulatory requirements.
- Provide oversight of external Biostats personnel and CROs to perform data analysis as agreed
- Writes and, when applicable, reviews and approves statistical methods sections of study protocols, statistical analysis plans, statistical analyses, and statistical input to reports and publications. Review clinical study protocols, providing statistical feedback and input on project design issues, endpoint definition and sample sizes
- Review Case Report Forms to ensure data is collected appropriately to achieve the analysis defined in the protocol
- Write and/or review Statistical Analysis Plans including Mock tables, listings and figures; Review programming specifications
- Ensure tables, listings, figures and statistical analysis programming is being done according to specifications
- Perform programming validation and ensures all Quality Control efforts have been followed
- Reviews and approves study database specifications, data management plans, data transfer plans, CDISC and ADaM specifications, and ensures reviews as needed by other appropriate function
- Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data
- Responds to questions from the FDA and other regulatory authorities on statistical issues.
REQURIED EDUCATION AND QUALIFICATIONS:
- A Master’s or Ph.D.’s degree in Statistics, Mathematics, or related field. Ph.D. is preferred
- Approximately 8+ years of related work experience in clinical trials or health research environment
- Experience managing clinical research vendors (CROs, Central Labs, etc.)
FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:
- Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
- Experienced as study lead and program lead statistician and contribute in strategy discussion in cross functional settings
- Experienced in study level work including authoring SAP and TFL specification
- Solid understanding of mathematical and statistical principles
- Familiar with SAS and R; advanced knowledge in CDISC including SDTM, ADaM, and controlled terminologies
- Experience supporting publication of analysis results
- As needed
Please fill out the form below to submit your application.