Director, Biostatistics

Insmed Incorporated•NJ Corporate Headquarters, NJ
•$185,000 - $252,500•Remote

About The Position

Insmed is seeking a Director, Biostatistics to join its Biometrics team within Clinical Development. Reporting to the Senior Director, Biostatistics, this role provides statistical leadership and expertise throughout the drug development process. The Director contributes statistical input to drug development plans, leads clinical trial design, analysis, and reporting, and engages with global regulatory agencies. The role also advances statistical innovation, promotes high-quality analyses, and fosters collaboration across teams. The position is fully remote and may be performed from anywhere. Minimal travel is expected, including occasional travel for team meetings or events.

Requirements

  • PhD in Statistics or Biostatistics.
  • 8+ years of experience in the pharmaceutical industry.
  • Strong knowledge of the pharmaceutical environment and broad experience with multi-phase development.
  • Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applicable to clinical research.
  • Strong project management, interpersonal, and communication skills.
  • A track record of successful contributions to submission dossiers (IND, CTD) and interactions with regulatory agencies or other external stakeholders.
  • Ability to influence and contribute to the advancement of innovative statistical methodology.

Nice To Haves

  • Experience with NDAs and MAAs is highly desired.

Responsibilities

  • Represent Biostatistics on cross-functional teams and be accountable for statistical aspects of clinical development plans, studies, submission activities, and regulatory interactions.
  • Lead one or several indications associated with one or several compounds in development.
  • Manage timelines and oversee the quality of statistical analyses conducted by CROs or internal teams.
  • Lead or contribute to statistical innovation activities, including innovative study design, advanced analytics, data visualization, and template development.
  • Independently address new and highly complex issues requiring advanced analytical thought.
  • Foster productive collaboration across Biometrics and cross-functionally, and communicate effectively with key stakeholders.
  • Lead and contribute to departmental projects.
  • Provide technical guidance and mentoring to junior statisticians.

Benefits

  • Comprehensive medical, dental, and vision coverage, mental health support, annual wellbeing reimbursement, and access to an Employee Assistance Program (EAP).
  • Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
  • 401(k) plan with a competitive company match, annual equity awards, participation in an Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance.
  • Company Learning Institute with access to LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities.
  • Employee resource groups, service and recognition programs, and opportunities to connect, volunteer, and give back.

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

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