Search Jobs

Principal Biostatistician - Medical Affairs (Remote)

Fairfield, CT

Posted: 08/10/2026 Industry: Biotech/Pharmaceutical Job Number: 6203

Job Description

We are partnering with a leading biopharmaceutical client seeking an experienced Principal Biostatistician to support its Medical Affairs Statistics, Epidemiology, and Real-World Evidence (RWE) organization. This individual will perform and validate statistical analyses in support of Medical Affairs initiatives while providing oversight of statistical and programming work conducted by external vendors as needed.

The Principal Biostatistician will collaborate closely with cross-functional Medical Affairs stakeholders on evidence-generation activities, including those incorporating real-world data and evidence. The role will provide statistical guidance on clinical and lifecycle management initiatives, advise on analytical strategies, and recommend appropriate methodological approaches to support integrated evidence generation and informed decision-making.

Essential Functions

  • Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of company products.
  • Contribute to publication objectives including timelines, statistical and analytical requirements for publications and projects.
  • Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
  • Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
  • Review publications, marketing materials, and education and training materials that contain clinical data and product claims
  • Stay informed with data being generated in current clinical development programs
  • Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
  • Collaborate and provide statistical support to the HEOR group in relevant areas including HTA and NTAP submissions.
  • Develop real world evidence strategies utilizing real-world data assets to design and execute RWE research projects, including the development of protocols and statistical analysis plans, in collaboration with epidemiology and RWE leadership team.
  • Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities.

Minimum Requirements

  • Master’s degree with >2 years of experience; OR PhD in statistics, mathematics or a related discipline with a statistical focus.
  • Proficient in drug development regulations pertinent to statistical analysis
  • Proficient SAS & R programming skills
  • Understanding of CDISC SDTM and ADAM models and standards is preferred, but not required.
  • Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.
  • Able to work in a fast-paced, flexible, team-oriented environment.

Meet Your Recruiter

Lauren Scutero
Associate Director, Recruitment

With 20 years of recruiting experience within Clinical Research, Lauren brings a relationship-first approach to every search. She is passionate about helping professionals navigate career transitions and is known for being open, honest, and resourceful. By leveraging the latest technologies and tools, she ensures candidates find not only the right role, but also the right company and culture. Her approach goes beyond placement, offering support through career coaching, salary negotiations, and post-placement guidance. For Lauren, building strong lasting relationships with both consultants and colleagues has always been the most meaningful part of her work. 

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Fairfield, CT

Ready to take your career to new heights? Explore job opportunities in beautiful Fairfield, Connecticut, where coastal charm meets bustling city life. This vibrant area offers a perfect blend of picturesque beaches, historic landmarks like the Fairfield Museum, delectable local cuisine, and a thriving arts scene including the Regina A. Quick Center for the Arts. With proximity to New York City and easy access to outdoor recreational activities at places like Lake Mohegan, Fairfield is an ideal location for professional growth and work-life balance. Don't miss out on the chance to join this dynamic community – browse our job listings today!