Remote Director Biostatistics

Summary

Join BridgeBio Pharma as a Director, Biostatistics to lead statistical and statistical programming teams at the product level. Contribute to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting clinical trial data.

Requirements

• PhD in statistics or biostatistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 11+ years relevant experience in the pharmaceutical/biotechnology industry
• NDA submission experiences
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
• Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions
• Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process
• Excellent programming skills in SAS and/or R
• 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

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
• CRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide CRO biostatisticians and statistical programmers
• Ensures deliverables are accurate and delivered according to the timelines
• Global Health Authority Interaction: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document
• May participate in meetings or teleconferences with Health Authorities
• 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
• Participate in cross-functional study-related activities; attend team meetings

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion