Director, Biostatistics
Role Overview
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, and engaging with global regulatory agencies.
You will also spearhead statistical innovation activities, ensuring high-quality statistical analyses and fostering collaboration across teams.
Full Job Posting
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:
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
Who You Are
You have a PhD in Statistics or Biostatistics along with 8+ years of experience in pharmaceutical industry. You are or you also have:
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 Have (but not required)
Experience with NDAs and MAAs is highly desired
Where You’ll Work
This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements
- Minimal travel expected
- #LI-Remote
- #LI-JK
Pay Range
- Life at Insmed
- At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
- Highlights of our U.S. offerings include:
- 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
- Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
- Current Insmed Employees: Please apply via the Jobs Hub in Workday.
About Insmed
Global biopharmaceutical company developing and commercializing medicines for patients with serious and rare diseases.
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