Associate Director/Director, Biostatistics - BridgeBio

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

Associate Director/Director, Biostatistics is 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. Successful candidates will also interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.  

Responsibilities

• Leads statistical and statistical programming team at product level
• 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. In collaboration with CRO, develop and maintain 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 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 update,s and other ad hoc safety analyses; participate in cross-functional study-related activities; attend team meetings

No matter your role at BridgeBio, successful team members are:

• 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

Education, Experience & Skills 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
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
• Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation
• 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
• Compliant with internal and external compliance practices to ensure the integrity of work and suggest innovative approaches to improve compliances and processes
• Excellent programming skills in SAS and/or R
• Excellent oral and written communication skills
• Knowledge of advanced clinical trial design concepts and an understanding of clinical/regulatory concepts
• 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 

What We Offer

• 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. 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