Sr Dir, Biostatistics

Responsibilities:
- Lead and guide a team of Clinical Biostatisticians to meet corporate regulatory, scientific, and business objectives.
- Collaborate with senior cross-functional leaders on strategic clinical development planning.
- Design and analyze Phase I–IV clinical studies using appropriate and innovative statistical methods; interpret and report results.
- Provide oversight of statistical and strategic content for regulatory interactions.
- Coordinate statistical work with outside organizations, CROs, and consultants.
- Identify and implement emerging clinical development approaches and new methodologies.
- Contribute to creation and development of department SOPs.
- Oversee vendors for KPIs, metrics, deliverables, and timelines.
- Support regulatory submissions (e.g., briefing books and integrated summary documents).

Qualifications:
- Ph.D. in Statistics or Biostatistics.
- 16+ years of clinical research and drug development experience.

Preferred:
- Recent/in-depth neuroscience experience.
- In-depth clinical trial methodology knowledge focused on registration and life-cycle management.
- Extensive US and non-US regulatory agency interaction experience.
- Strong analytical, communication, and interpersonal skills; able to educate non-scientists.
- Detail-oriented, able to work under pressure; flexible to changing priorities.

Work/Travel:
- Hybrid: onsite at Waltham, MA at least 3 days/week (60% office / 40% home); not fully remote.
- Travel up to 15% domestic and international.

Compensation:
- Annual base salary: $274,820–$293,881; eligible for annual performance bonus; competitive benefits package.