Biostatistician, Regulatory Submissions

Analysis Group•Boston, MA

8d•Onsite

About The Position

Analysis Group is seeking an experienced professional to support the continued growth of our clinical trial and biostatistics capabilities. This role is suited for candidates with a strong foundation in clinical trial data, statistical programming, and regulatory processes who are interested in applying their expertise in a consulting environment. Biostatisticians play a key role in leading analytical workstreams, guiding project teams, and contributing to strategic decision-making across a diverse portfolio of client engagements. Analysis Group fosters a work environment that is centered on delivering high-quality work through teamwork and collaboration, best-in-class learning programs, and a culture of transparency, trust, and respect. We are looking for candidates who demonstrate both technical expertise and strong interpersonal skills, and who are passionate about applying data and analytics to real-world challenges in the life sciences industry.

Requirements

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 3-5+ years of experience in clinical trials, pharmaceutical, biotech, or CRO environments
An ideal candidate will have spent the last 3-5 years in a biotechnology or pharmaceutical company
Experience in early- to late-phase clinical trial design and regulatory evidence strategy
Experience supporting or contributing to clinical phase regulatory submissions for the US FDA and other regulatory authorities.
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
While prior consulting experience is not required, candidates should demonstrate strong potential for client-facing work and structured problem solving
Prior experience collaborating across cross-functional stakeholders (e.g., clinical, regulatory, HEOR)
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
Candidates must be legally authorized to work in the United States at the time of hire.
Analysis Group may consider candidates who require visa sponsorship, consistent with business needs.

Nice To Haves

While not required, a plus would be experience with post-marketing evidence generation, including label expansion strategies, PASS/PAES, Phase IV studies, and the use of real-world evidence to support regulatory decision-making

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
Direct data integration, cleaning, and transformation efforts across clinical trial and real-world data sources
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