Director / Senior Director, Biostatistics (Medical Affairs)

A late-stage biotech focused is looking to bring on a Director / Senior Director, Biostatistics to own the backbone of its medical affairs, publication and scientific exchange activities. This is a highly visible hands-on role, as the company moves into its post-approval phase.

Responsibilities

• Lead statistics for the publication, congress and scientific exchange pipeline across approved and pipeline programs
• Own all statistics relating to manuscripts, congress abstracts, posters and advisory board materials, ensuring consistency across all external-facing outputs
• Design and deliver integrated, cross-program analyses, including integrated safety reporting
• Partner with Clinical, Medical Information and Commercial on ad hoc data cuts, standard response documents and payer-facing analyses
• Provide rapid-turnaround support for journal reviewer queries and sensitivity analyses
• Support MLR review, ensuring statistical claims are backed by source data
• Contribute to biostatistics strategy for ex-US regulatory filings and payer dossiers
• Contribute to publication planning
• Support clinical development biostatistics and programming as needed

Experience Required

• PhD in Biostatistics or Statistics; Masters with supplementary experience considered
• 7+ years of statistics and programming experience in clinical-stage drug development
• Experience supporting publications, congresses or scientific exchange within pharma or biotech
• Small or midsize biotech experience preferred, with larger pharma backgrounds considered for those who thrive in a hands-on, fast-paced setting
• Confident working with medical affairs, commercial and pharmacovigilance stakeholders, and presenting to non-statistical audiences

Compensation DOE - $230 - $300k salary + bonus, equity and supporting package