Senior Biostatistician, Regulatory Submissions

About the Senior Biostatistician Position:Analysis Group is seeking an experienced biostatistics professional to support the continued growth of our clinical development and regulatory strategy practice. This role is particularly well suited for candidates who have applied biostatistical expertise within pharmaceutical or biotechnology clinical development and are interested in bringing that experience to a strategic, client-facing consulting environment. We are particularly interested in candidates with hands-on experience supporting regulatory submissions in a pharmaceutical or biotechnology setting, including contributing statistical expertise to a major regulatory submission.

The role offers the opportunity to apply deep statistical and regulatory expertise across a diverse portfolio of clients, products, therapeutic areas, and development-stage challenges, while working alongside experts across biostatistics, clinical research, epidemiology, HEOR, data science, and regulatory strategy. Our work is innovative, rigorous, and intellectually enriching: biostatisticians help address novel clinical development and regulatory questions, shape fit-for-purpose analytical approaches, and contribute to evidence strategies that inform high-stakes decisions for life sciences clients. 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. Responsibilities may include: 

• Apply biostatistical and regulatory expertise 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.
• Develop rigorous, innovative analytical approaches to address novel client questions and complex regulatory challenges.
• Contribute to business development efforts and support ongoing client relationships.
• Participate in dissemination of research through publications, presentations, and regulatory documentation. 

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. Prior consulting experience is not required. We are particularly interested in industry professionals who are excited to apply their clinical development and regulatory experience in a client-facing environment and who demonstrate strong communication, judgment, and structured problem-solving skills. Specifically, we seek candidates with:

• Advanced degree (PhD preferred, Master’s considered) in Biostatistics, Statistics, Epidemiology, or a related quantitative field.
• A minimum of 3 years of substantive relevant experience is required. We are open to candidates at different career stages, with role scope and responsibilities calibrated to the candidate’s experience and expertise.
• 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. 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; candidates should demonstrate strong potential for client-facing work, sound judgment, and structured problem solving.
• Prior 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.
• Experience serving as a statistical lead for a regulatory submission is highly valued.
• 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.
• 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. 

Please submit your application and curriculum vitae through the Analysis Group website. You may also choose to include a cover letter, graduate transcripts, or publications as supplemental materials; however, these are optional and not required for consideration.

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.

Analysis Group offers competitive compensation and a comprehensive benefits package. The estimated salary range for this position is $195,000–$255,000. Compensation offered will be based on a number of factors including work experience, education, and skill level. This role is eligible for a discretionary annual bonus that is determined in large part by individual performance. To learn more about our benefit offerings, click here.