Director of Statistical Programming

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

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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