Director of Statistical Programming New Remote - USA

BridgeBio Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 242,000 - 269,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model with flexibility

100% employer-paid medical, dental, &

Vision premiums for you & dependents

HSA with employer contributions

Flexible Spending Accounts (FSA)

Fertility & family-forming benefits

Mental health support

Parental leave

Job summary

BridgeBio Inc. is seeking a Director of Statistical Programming to lead programming activities for multiple clinical studies and regulatory submissions, performing hands‑on work while guiding CRO deliverables and cross‑functional collaboration.

The role requires 10+ years in statistical programming (MS), deep CDISC FDA knowledge, and experience in NDA/BLA submissions. You will establish SAS environments, advance automation with AI tools, and drive standards across the organization.

Qualifications

• MS in Statistics, CS, or related field with 10+ years, or BS with 12+ years.
• Minimum 5 years as lead statistical programmer.
• Extensive knowledge of CDISC standards and FDA SDTM.
• Experience in NDA/BLA submissions and regulatory requirements.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Lead and manage statistical programming activities for multiple clinical studies.
• Review CRO deliverables for accuracy and regulatory compliance.
• Coordinate with internal/external teams for results reporting and submissions.
• Set up SAS reporting environment and automate delivery, including AI-assisted tools.
• Represent the statistical programming function in cross-functional study teams.
• Develop and maintain programming standards and SOPs.

Skills

Statistical programming

CDISC standards

Regulatory compliance

AI in pipelines

CRO oversight

Project management

Education

MS in Statistics or Computer Science

BS in Statistics or Computer Science

Tools

SAS

Job description

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 together under one financial umbrella to reduce risk and unleash innovation. This model allowsscience and small teams of experts to lead the way. We build bridges to groundbreaking advancements in raredisease, anddevelop 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’llask"why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You'll Do

The Director of Statistical Programming will lead statistical programming activities for multiple studies and programming submission-related activities. In addition to working as a hands‑on programmer for various internal requests, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions.

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.

Where You'll Work

This is a U.S.-based remote role that will require bi-annually, or as needed visits to our San Francisco Office.

Who You Are

• 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 of CRO oversight preferred
• 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
• Experience integrating AI tools into clinical data pipelines and statistical workflows is highly desirable

$241,600 - $269,200 USD

As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For BridgeBio Full-Time U.S Based Roles:

• Market-leading compensation
• 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
• HealthSavings 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

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, continuouseducationand professional development programs via LinkedIn Learning,LifeLabs, &BetterUpCoaching
• We celebratestrong performancewith financial rewards, peer-to-peer recognition, and growth opportunities