Sr. Director, Biostatistics

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “Moneyball for biotech” approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You’ll Do

The Sr. 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 to prepare analysis files and perform statistical analyses. 

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. 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
• Provide statistical input and methodological evaluation/advice to meet commercial and publication needs
• 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

Where You’ll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.

Who You Are

• 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
• Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions
• NDA submission experiences preferred
• 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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities