About the role
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.
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
(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.
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
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
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:
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
Health & Well-Being
- 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
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
02 Aplyr's read
BridgeBio Pharma is a dynamic biotechnology firm dedicated to tackling genetic diseases and cancers, attracting professionals passionate about impactful medical advancements.
What's promising
- •BridgeBio focuses on innovative treatments for genetic diseases, offering significant potential for groundbreaking medical advancements.
- •The company has a robust pipeline with multiple late-stage clinical trials, indicating strong future growth prospects.
- •BridgeBio's strategic partnerships enhance its research capabilities and expand its therapeutic reach.
What to watch
- •The company faces high financial risk due to significant R&D expenditures without guaranteed success.
- •BridgeBio operates in a highly competitive market with numerous established players.
- •Regulatory hurdles for drug approvals can delay product launches and impact revenue.
Why BridgeBio Pharma
- •BridgeBio's focus on genetic diseases and cancers sets it apart in the biotechnology sector.
- •The company's decentralized model allows for nimble and efficient project management.
- •BridgeBio's commitment to rare diseases addresses unmet medical needs, differentiating its mission.
Aplyr’s read is generated by AI from public sources. Was it useful?
03 About BridgeBio Pharma
BridgeBio is a biotechnology company focused on developing and commercializing medicines for genetic diseases and cancers.
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