Senior Director, Project Management

1 month ago


California, United States Penfield Search Partners Ltd Full time

Our client is a biopharmaceutical company with marketed product, a robust pipeline and solid financials, focused in the Rare Disease area. They are currently seeking a Director of Biostatistics to be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, and manage CRO programmers and statisticians in preparing analysis files and performing statistical analyses.

Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies. Develop and maintain SAPs, including derived variables, templates of statistical tables, figures, and listings
collaborate closely with data manager to ensure high-quality data
Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines
Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc safety analyses; D. in statistics or biostatistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry
Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
Excellent programming skills in SAS and/or R
This position can be remote with travel to SF Bay Area as necessary.
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