Senior Manager, Biostatistics
Insmed Incorporated
Summary
We're looking for a Senior Manager, 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 provide statistical expertise for clinical trial(s) within one or more compounds in development. You will support the design, setup, execution, analysis, and reporting of clinical studies, and contribute as a key member of cross-functional teams. The position requires solid technical and communication skills, and the ability to work independently with moderate guidance.
Job description
What You'll Do
In this role, you'll have the opportunity to provide statistical input into protocol development, statistical analysis plans, and other key trial documents. You'll also:
- Support study setup activities including randomization, sample size justification, and selection of appropriate analysis methods
- Perform or oversee statistical analyses of clinical trial data to ensure timely and accurate reporting
- Contribute to the preparation of clinical study reports, regulatory submissions, and responses to health authority queries
- Collaborate with cross-functional teams (clinical, programming, data management, regulatory) to ensure statistical integrity and compliance
- Review and provide feedback on deliverables from CRO partners or internal programming teams
- Assist in the development and implementation of departmental standards and infrastructure initiatives
- Stay current with relevant statistical methodology and regulatory guidance, and apply as appropriate
Who You Are
You have a PhD in Statistics/Biostatistics along with 2+ years of relevant pharmaceutical experience. You are or you also have:
- Strong knowledge of statistical concepts and techniques commonly used in clinical development
- Familiarity with regulatory requirements and guidelines for clinical research
- Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to clinical research
- Excellent project management, interpersonal and communication skills
- Ability to work independently, manage multiple priorities, and collaborate effectively in a team environment
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.
Requirements
- PhD in Statistics/Biostatistics
- 2+ years of relevant pharmaceutical experience
- Strong knowledge of statistical concepts and techniques commonly used in clinical development
- Familiarity with regulatory requirements and guidelines for clinical research
- Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to clinical research
- Excellent project management, interpersonal and communication skills
- Ability to work independently, manage multiple priorities, and collaborate effectively in a team environment
Benefits
- Medical, Dental & Vision
- Mental health support
- Annual wellbeing reimbursement
- Employee Assistance Program
- Paid time off
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules
- 401(k) plan
- Company match
- Annual equity awards
- Employee Stock Purchase Plan
- Life insurance
- Disability insurance
- LinkedIn Learning access
- Mentorship programs
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.