Biostatistics Director, Medical Affairs

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.

Job Title

Biostatistics Director, Medical Affairs

Job Summary:

The Director of Medical Affairs Biostatistics is responsible for statistical activities in support of external-facing scientific communication. This includes, but is not limited to, providing scientific and methodological expertise to support medical strategy, publications, and external engagements; serving as the primary point of contact between biostatistics and the Medical Affairs team; collaborating with the team in development of publication strategy plans; maintaining and executing Supplemental Statistical Analysis Plans (SAPs); and assisting as needed with real-world evidence-generating requests. They interact with both internal and external cross-functional study teams to support the scientific communication effort, and partner with unblinded biometrics study team members to deliver needed statistical output in a timely fashion.

Responsibilities:

· Leads the statistical and statistical programming efforts for medical publications, scientific congresses, and external collaborations

· Guides statistical design and analysis for investigator-initiated research and collaborative studies

· Provides statistical input to strategic planning of publication strategy plans

· Develops and maintains Supplemental SAPs

· Provides guidance to Medical Affairs team on all aspects of statistical activities to ensure methodological rigor

· Works collaboratively with Medical Affairs, Project Management, Translational Medicine, and other staff to meet scientific communication timelines

· Provides feedback to the Medical Affairs team regarding what is and is not possible with available data and partners with the team to brainstorm creative, scientifically sound approaches to address key questions

· Interacts with the team to prospectively plan publication strategies for future congresses and manuscript generation efforts.

· Works with the team to develop idea-generating analyses, including ad hoc and exploratory data analyses (EDA), to inform scientific insights and evidence-generation opportunities

· Serves as the primary point of contact for Medical Affairs requests and collaborates closely with Clinical Biostatistics and Statistical Programming leads on relevant protocols

· Assists, as needed, with Health Economics and Outcomes Research (HEOR) and real-world evidence (RWE) evidence-generation requests.

Where You'll Work:

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

Qualifications:

PhD in statistics or biostatistics with 8+ years relevant experience in the pharmaceutical / biotechnology industry or MS in statistics or biostatistics with 15+ years relevant experience in the pharmaceutical / biotechnology industry

Experienced in post-approval / Medical Affairs settings

Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments