Director, Biostatistics

Insmed Incorporated

1d • Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: 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 Executive 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, and engaging with global regulatory agencies. You will also spearhead statistical innovation activities, ensuring high-quality statistical analyses and fostering collaboration across teams. What You'll Do: 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:

Requirements

• You have a PhD in Statistics or Biostatistics along with 8+ years of experience in 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

Nice To Haves

• Experience with NDAs, and MAA’s is highly desired

Responsibilities

• 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

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 with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree