Associate Director, Biostatistics

Summary

Join QED Therapeutics, a BridgeBio Pharma affiliate, as an Associate Director of Biostatistics. You will play a key role in supporting clinical trials, from design and protocol development to data analysis and regulatory submissions. Collaborate with internal and external teams, including CROs, to ensure high-quality statistical work. This position requires a PhD or MS in biostatistics with relevant experience in the pharmaceutical industry. You will demonstrate leadership, excellent communication, and proficiency in statistical programming. BridgeBio offers a competitive compensation and benefits package, including flexible PTO, opportunities for career advancement, and a collaborative work environment.

Requirements

• Ph. D. in statistics or biostatistics and 5+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 8+ years relevant experience in the pharmaceutical/biotechnology industry
• Proven knowledge and expertise in statistics and its applications to clinical trials
• Team player with the ability to work successfully across functions
• Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's terms
• Demonstrated leadership skills
• Proficiency with statistical programming in SAS and/or R
• Knowledgeable in CDISC standards, including SDTM, ADaM
• Familiar with ICH guidelines, FDA, and other regulatory authority guidance

Responsibilities

• Provide statistical input to study design, protocol development, sample size calculation, Case Report Form, Results Interpretation, clinical study report, and addressing questions from regulatory agencies
• Collaborating with CRO, develop and maintain SAPs, including the derived variables, the templates of statistical tables, figures, and listings, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications
• Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high-quality data
• Works collaboratively with Statistical Programmers, Biostatisticians, 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

Preferred Qualifications

Preferably NDA experience, including eCTD submission

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
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• 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