Eidos Therapeutics and BridgeBio Pharma are seeking a Sr. Director, Biostatistics to support clinical trials and contribute to the development of transformative medicines for patients with genetic diseases and cancers.
Requirements
- PhD in statistics or biostatistics and 10+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 13+ 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
- NDA submission experiences preferred
Responsibilities
- Leads statistical and statistical programming team at the product level
- Provides statistical input to strategic planning, study design, protocol development, sample size calculation, Case Report Form, Results Interpretation, clinical study report, and addressing questions from regulatory agencies
- Develops and maintains SAPs, including the derived variables, the templates of statistical tables, figures, and listings
- Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high-quality data
- Works 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
- Coordinates with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc safety analyses
- Participates in cross-functional study-related activities; attends team meetings
Other
- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
- Excellent oral and written communication skills
- Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors
- Education: PhD in statistics or biostatistics and 10+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 13+ years relevant experience in the pharmaceutical/biotechnology industry
