[Hiring] Director, Biostatistics @Insmed Incorporated

Role Description

We’re looking for a Director, Biostatistics on the Biometrics team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Biostatistics, you’ll play a pivotal role within the Clinical Development organization, responsible for providing statistical leadership and expertise throughout the drug development process.

This position involves:

• Statistical input into drug development plans
• Leading the design, analysis, and reporting of clinical trials
• Engaging with global regulatory agencies
• Spearheading statistical innovation activities
• Ensuring high-quality statistical analyses
• Fostering collaboration across teams

In this role, you’ll have the opportunity to represent Biostatistics as a member of cross-functional teams, accountable for statistical aspects of clinical development plans, studies, submission activities and regulatory interactions. You’ll also:

• Lead one or several indications corresponding to one or several compounds in development
• Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams
• Lead or contribute to statistical innovation activities including innovative design, advanced analytics, data visualization and template development
• Independently undertake new and highly complex issues requiring advanced analytical thought
• Foster productive collaboration across Biometrics and cross-functionally, while effectively communicating with key stakeholders
• Lead and contribute to departmental projects
• Provide technical guidance and mentoring to Junior statisticians

Qualifications

• PhD in Statistics or Biostatistics
• 8+ years of experience in the pharmaceutical industry
• Strong knowledge of 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 contribution to submission dossiers (IND, CTD) and interactions with regulatory agencies or other external stakeholders
• Ability to influence and to contribute to the advancement of innovative statistical methodology

Requirements

• Experience with NDAs and MAAs is highly desired

Benefits

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