Associate Director, Biostatistics The Lotus Group is recruiting on behalf of a commercial-stage biopharmaceutical company seeking an Associate Director of Biostatistics to provide statistical leadership across clinical development programs. The position may be fully remote within the United States, with a hybrid option available in the Greater Boston area. Visa sponsorship is available for qualified candidates.
This role offers the opportunity to contribute beyond leading individual clinical studies, with meaningful involvement in broader clinical development strategy, regulatory activities, and cross-functional decision-making. Working within a scientifically rigorous environment, the Associate Director will influence trial designs and development plans, contribute to regulatory submissions and health-authority interactions, and collaborate closely with experienced scientific and cross-functional colleagues.
Key Responsibilities
Provide statistical leadership for clinical development programs and cross-functional study teams.
Contribute to clinical development plans and the design of clinical trials.
Develop statistical content for study protocols and author statistical analysis plans.
Advise study teams on statistical considerations throughout trial planning, execution, analysis, and reporting.
Partner with Data Management and Clinical Operations on eCRF design and data-collection strategy.
Collaborate with Statistical Programming on analysis datasets, tables, listings, figures, and interpretation of study results.
Develop analysis specifications and support additional or exploratory analyses as needed.
Contribute statistical content to clinical study reports, regulatory submissions, safety reports, briefing packages, and other development documents.
Present and interpret clinical data for senior leadership, external experts, partners, and health authorities.
Support scientific publications, conference presentations, and other external communications.
Oversee statistical and programming work performed by CROs and other external partners.
Provide statistical consultation to research and preclinical colleagues when needed.
Qualifications
PhD in Biostatistics, Statistics, or a closely related discipline with at least 7 years of biostatistics experience in the pharmaceutical or biotechnology industry.
Demonstrated experience supporting clinical trials and working as a study or program statistician.
Strong knowledge of clinical trial design, statistical analysis, and interpretation of clinical data.
Experience authoring protocols, statistical analysis plans, analysis specifications, and clinical or regulatory documents.
Proficiency with SAS.
Excellent written, verbal, and presentation skills.
Ability to communicate statistical concepts clearly to both technical and nontechnical stakeholders.
Working knowledge of applicable regulatory requirements, Good Clinical Practice, and pharmaceutical industry standards.
Preferred Experience
Experience supporting late-stage clinical development, including Phase 3 trials and marketing applications.
Previous responsibility as the lead statistician for a compound or clinical development program.
Experience contributing to meetings or written interactions with the FDA or other global regulatory authorities.
Familiarity with CDISC standards, including SDTM and ADaM.
Experience with R and clinical-trial design or sample-size software.
Experience designing or supporting adaptive clinical trials.
Background managing CRO statisticians, programmers, or other external partners.
This position offers a high-visibility opportunity to contribute to clinical development strategy while working with an experienced, collaborative, and scientifically focused team.