Biostatistician, Regulatory Submissions

About the role

Analysis Group is a leading international economics consulting firm founded in 1981 with over 1,500 professionals worldwide. Our health care experts apply analytical expertise in health economics and outcomes research (HEOR), clinical research, market access and commercial strategy, health care policy, epidemiology and drug safety, data science, and biostatistics. We collaborate with leading academics and industry partners to provide comprehensive consulting services globally.

Responsibilities

• Apply biostatistical methods to support clinical development, regulatory submissions (e.g., FDA, EMA), and evidence generation strategies
• Contribute to strategic advising on clinical trial design, analysis strategy, and interpretation of results
• Oversee implementation of statistical analysis plans (SAPs) and ensure high-quality, reproducible analytical outputs
• Manage and mentor teams of analysts and associates, providing guidance on technical execution and professional development
• Develop tools, programming standards, and best practices to enhance efficiency and scalability of analyses
• Communicate findings to technical and non-technical audiences, including translating complex analyses into clear, actionable insights
• Contribute to business development efforts and support ongoing client relationships
• Participate in dissemination of research through publications, presentations, and regulatory documentation

Qualifications

• Advanced degree required (PhD preferred, Master’s considered) in Biostatistics, Statistics, Epidemiology, or a related quantitative field
• A minimum of 3 years of substantive relevant experience required
• An ideal candidate will have 3-10 years of experience in clinical trials, pharmaceutical, biotech, or CRO environments
• Experience in early- to late-phase clinical trial design and regulatory evidence strategy
• Direct participation in regulatory interactions is a plus
• Excellent judgement, problem-solving, and communication skills, with the ability to translate complex technical concepts into clear, structured insights for clients
• Prior consulting experience is not required, but strong potential for client-facing work and structured problem solving is desired
• Experience managing analyses, including SDTM, ADaM, and TLF development
• Demonstrated ability to manage multiple workstreams and meet deadlines
• Interest in mentoring and developing junior team members
• Collaborative mindset and ability to work across interdisciplinary teams