A clinical-stage biopharma is looking to engage a Senior Director, Biostatistics to support the design, analysis, interpretation and reporting of clinical studies, as well as regulatory and payer submissions.

The company is heading into a pivotal stretch of regulatory activity, with this hire playing a central role.

Responsibilities

• Lead and serve as the primary point of contact for biostatistics on assigned clinical studies
• Oversee deliverables in partnership with biostatistical programming and program management colleagues, across studies, integrated analyses and ad hoc or post-marketing safety work
• Contribute to regulatory strategy for NDA-enabling activities alongside other functional leads
• Act as the point of contact for ongoing NDA-enabling workstreams with external collaborators
• Coordinate assigned biometric activities within data management and programming teams
• Support the development of relevant policies and procedures

Experience Required

• PhD or MS in a relevant field, with 7+ years of post-graduate statistics experience in clinical-stage drug development
• 3+ years within a small or midsize biotech, working on late-stage programs
• Experience leading biostatisticians and/or biostatistical programmers on regulatory-facing deliverables, with an enterprise mindset
• Direct biostatistical programming experience preferred
• Strong track record managing multiple projects, with excellent oral and written communication skills
• Solid understanding of regulatory and industry trends, including experience developing policies and SOPs
• Comfortable operating in fast-paced, entrepreneurial environments

Compensation DOE - $220,000 - $290,000 base salary + benefits