Biostatistics Director, Medical Affairs

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.

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

• Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions 

• Established publication record and experience supporting scientific communication 

• Able to work effectively in cross-functional, matrixed environments

• Excellent written and verbal communication sk