Note: The job is a remote job and is open to candidates in USA. BridgeBio is a biopharmaceutical company developing life-changing medicines for patients with unmet needs, particularly in rare disease. The Director of Statistical Programming will lead statistical programming activities across multiple clinical studies, oversee CRO deliverables, and support results reporting and regulatory submissions. The role also guides programming standards, infrastructure, automation, and cross-functional collaboration.
Responsibilities
- Lead and manage statistical programming activities for multiple clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency
- Review CRO deliverables and perform acceptance check and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards
- Manage, review, and/or execute statistical programming deliverables related to study monitoring, clinical study reports, data integrations, and regulatory query responses
- Collaborate with external alliances for all programming-related tasks to ensure successful and effective coordination and communications
- Set up SAS reporting environment, programming infrastructure, and utility macros library; Help bring state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI-assisted tools to improve programming efficiency, quality, regulatory and GDPR compliance
- Represent the statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines
- Identify, develop and maintain statistical programming standards, processes, and SOPs
Skills
- MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience, or BS in Statistics, Computer Science, or a related field with 12+ years of relevant experience. Minimum of 5 years of experience as a lead statistical programmer
- Extensive knowledge of CDISC standards and FDA SDTCG
- Experience in NDA/BLA submission and advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
- Experience with statistical programming methods and processes in clinical development
- Ability to manage multiple projects in a fast-paced environment
- This is a U.S.-based remote role that will require bi-annually, or as needed visits to our San Francisco Office
- Experience of CRO oversight preferred
- Experience integrating AI tools into clinical data pipelines and statistical workflows is highly desirable
Benefits
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Hybrid work model with flexibility
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave to care for yourself and your family
- Endless opportunities for skill development and internal mobility
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- Financial rewards, peer-to-peer recognition, and growth opportunities
Company Overview
Company H1B Sponsorship