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Director of Statistical Programming

BridgeBio · Remote - USA · Remote

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About BridgeBio

BridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Backed by Sequoia.

About the role

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 .

What they're looking for

  • 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
More about this 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.

The Director of Statistical Programming will lead statistical programming activities for multiple studies and programming submission-related activities. In addition to...

Read the full posting on BridgeBio's site ↗

Biostatistics/Data Mgmt

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