Principal Biostatistician - Medical Affairs (Remote)

Job Description

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.