Biostatistician, Regulatory Submissions

Overview About Analysis Group’s HEOR, Epidemiology, & Market Access Practice:Make an impact at Analysis Group, where we collaborate with our clients to develop and implement regulatory and analytical strategies to support life sciences products throughout their life cycles. Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,500 professionals across 15 offices, including more than 250 professionals who focus on health care. Analysis Group’s 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. Analysis Group’s internal experts, together with its network of affiliated experts from academia, industry, and government, provide our clients with exceptional breadth and depth of expertise and end-to-end consulting services globally.We draw upon our deep expertise to provide innovative, data-driven strategies for clients in the life sciences industry across all phases of product development and commercialization.We help our clients define markets, demonstrate value, and inform business decisions throughout product lifecycles.We have a broad range of expertise and collaborate with leading academics in our areas of expertise to offer cutting-edge analyses and analytical tools to address business and clinical challenges that require rigorous, evidence-based research.We are distinguished by the way we integrate our capabilities to provide our clients with a comprehensive approach to problem solving.We apply our analytical expertise to support pro bono initiatives that address critical public health and social issues. Our work includes collaborations with organizations such as GHESKIO in Haiti to develop digital tools that improve HIV clinic operations and patient outcomes, and Partners in Health in Lesotho to evaluate maternal and child health, HIV, and TB treatment outcomes. These efforts have been recognized by the Boston Bar Association’s President’s Award and highlighted at the International AIDS Society Conference, underscoring our commitment to using data and evidence-based research to advance global health and social impact.We have also been recognized as a best place to work in several top surveys, including national surveys by Glassdoor (Best Places to Work, Employees’ Choice Award, small and medium business category) and Vault (17th overall in the Vault Consulting 50, and the top-ranked economic consulting firm).About the Biostatistician 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. Responsibilities may include: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 documentationAnalysis 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. Specifically, we seek candidates with: 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 requiredAn ideal candidate will have 3-10 years of experience in clinical trials, pharmaceutical, biotech, or CRO environmentsAn ideal candidate will have spent the last 3-10 years in a biotechnology or pharmaceutical companyExperience 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 plusExcellent judgement, problem-solving, and communication skills, with the ability to translate complex technical concepts into clear, structured insights for clientsWhile 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 teamsWhile 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-makingCandidates 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.Analysis Group embraces equal opportunity. We are committed to building teams that bring a variety of backgrounds, perspectives, and skills, as we believe that a strong and inclusive workforce directly supports our goal of providing the highest-quality work. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or any other class protected under applicable federal, state, or local law, and we encourage candidates of all backgrounds to apply. Privacy Notice For information about Analysis Group’s privacy practices, please refer to the applicable Analysis Group privacy policy. ­ Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.Please view the EEOC’s “Know Your Rights” poster here.Job SummaryCategory: General