Director of Statistical Programming

United StatesRemoteexecutive

OtherDirector

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Quick Summary

Overview

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,

Technical Tools

OtherDirector

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 together 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 disease, 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. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Responsibilities

~2 min read

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.

(5-7 bullets max)

→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.

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

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

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

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$241,600—$269,200 USD

What We Offer

~1 min read

For BridgeBio Full-Time U.S Based Roles:

Financial & Rewards

✓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

✓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

✓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, & BetterUp Coaching

✓We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities