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Insmed

Develops therapies for rare diseases

Senior Manager - Biostatistics

Quantitative Biology & BiostatisticsUpdated on Nov 13
Full-timeRemote in USA

About the Job

Requirements

  • A PhD in Statistics or Biostatistics and at least 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.

Responsibilities

  • Provide statistical expertise for clinical trials within one or more compounds in development.
  • Support the design, setup, execution, analysis, and reporting of clinical studies as a key member of cross-functional teams.
  • Provide statistical input into protocol development, statistical analysis plans, and other key trial documents.
  • 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 clinical, programming, data management, and regulatory teams 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 it as appropriate.

About the Company

Insmed

Develops therapies for rare diseases

Insmed focuses on developing and delivering therapies for serious and rare diseases. Its products come from a pipeline of clinical trials and approved treatments, sold to patients in global markets with offices in Bridgewater, NJ, Europe, and Japan. The company’s work combines research and development, regulatory approvals, and commercialization to bring therapies from discovery to patients. Insmed differentiates itself by addressing unmet medical needs in rare diseases and maintaining a global infrastructure that supports development, approval, and patient access. The goal is to improve patient outcomes by providing effective treatments for conditions with limited existing options.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
1988

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