Summary

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.

Job description

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 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.

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. Minimal travel expected.

Requirements

PhD in Statistics or Biostatistics
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

Benefits

Medical, Dental & Vision
Mental Health Support
Annual Wellbeing Reimbursement
Employee Assistance Program
Paid Time Off
Fertility & Family-Forming Benefits
Caregiver Support
Flexible Work Schedules
401(k) Matching
Annual Equity Awards
Employee Stock Purchase Plan
Life & Disability Insurance
LinkedIn Learning Access

Company overview

Insmed Incorporated is a people-first global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan, the company focuses on delivering first- and best-in-class therapies for underserved patient communities. Insmed's portfolio includes two approved therapies for chronic lung diseases: ARIKAYCE for Mycobacterium avium complex lung disease and BRINSUPRI for non-cystic fibrosis bronchiectasis. The company is advancing a diverse pipeline of mid- to late-stage investigational medicines and cutting-edge drug discovery programs spanning gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue technologies. Recognized as the No. 1 Science Top Employer for five consecutive years, Insmed employs 1,001-5,000 professionals globally and maintains a strong commitment to innovation, patient-centricity, and corporate responsibility.