Senior Biostatistician — Regulatory Submissions & Strategy

Analysis Group, Inc.; Boston (MA); On-site; USD 195,000 - 255,000; Full time

Job summary

Analysis Group seeks an experienced biostatistician to support growth in our clinical development and regulatory strategy practice. This role suits candidates with hands-on biostatistical expertise in pharma or biotech who are excited by a client-facing consulting environment.

You will work across biostatistics, epidemiology, HEOR, and regulatory strategy on diverse projects, contributing to regulatory submissions (FDA/EMA), study design, analysis plans, and mentorship of junior staff.

Qualifications

• Advanced degree (PhD preferred, Master’s considered) in Biostatistics, Statistics, Epidemiology, or a related quantitative field.
• Minimum of 3 years of substantive relevant experience.
• 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, including contributing statistical expertise to a major regulatory submission.
• 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; candidates should demonstrate strong potential for client-facing work, sound judgment, and structured problem solving.
• Experience collaborating across cross-functional stakeholders (e.g., clinical, regulatory, HEOR).
• Experience overseeing statistical analyses and deliverables for regulatory submissions, including SAPs, TLFs, and CDISC-compliant SDTM and ADaM datasets.

Responsibilities

• Apply biostatistical and regulatory expertise to support clinical development, regulatory submissions (e.g., FDA, EMA), and evidence generation strategies.
• 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.
• Develop rigorous, innovative analytical approaches to address novel client questions and complex regulatory challenges.
• Contribute to business development efforts and support ongoing client relationships.

Skills

Biostatistics

Regulatory submissions

Clinical development

Trial design

Team mentorship

Education

PhD in Biostatistics/Statistics/Epidemiology

Masters considered

Tools

CDISC SDTM

ADaM

Job description

Analysis Group seeks an experienced biostatistician to support growth in our clinical development and regulatory strategy practice. This role suits candidates with hands-on biostatistical expertise in pharma or biotech who are excited by a client-facing consulting environment.

You will work across biostatistics, epidemiology, HEOR, and regulatory strategy on diverse projects, contributing to regulatory submissions (FDA/EMA), study design, analysis plans, and mentorship of junior staff.