Lead Biostatistician – Pharmacovigilance, PV

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Directs the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-centric observational studies utilizing complex longitudinal registry data.

• Works collaboratively with investigators, epidemiologists, clinicians, and clients to create protocols, Statistical Analysis Plans (SAPs), and analytic strategies that align with client goals and regulatory obligations.

• Conducts advanced statistical analyses and sample size/power calculations independently, adhering to SAPs and industry best practices.

• Offers strategic statistical guidance and independently makes informed statistical decisions regarding safety analyses and the generation of real-world evidence.

• Supervises and mentors Biostatistician I/II analysts and other junior staff, ensuring the quality, accuracy, and consistency of statistical analyses and documentation.

• Creates and enacts standardized methodologies, analytical templates, and programming techniques to enhance efficiency, reproducibility, and consistency across projects.

⛳️ Requirements

• PhD in Biostatistics, Statistics, or Mathematics is preferred; a master’s degree in these fields is required.

• A minimum of 5–8 years of practical statistical experience in clinical research, pharmaceuticals, biotechnology, CRO, hospital, or academic settings is required.

• Proven experience leading complex observational research studies, equivalent to 3 years, is necessary.

• Preferred experience includes leading projects focused on Pharmacovigilance or safety analyses.

• Required experience working with complex longitudinal registry or real-world data.

• Demonstrated understanding of retrospective and prospective observational study designs and associated methodologies is required.

• Strongly preferred experience with causal inference theory and methods.

• Preferred experience in supporting regulatory safety studies, post-authorization safety studies (PASS), or related pharmacovigilance initiatives.

• Experience mentoring or supervising junior biostatisticians is preferred.

• Collaborative research experience with publications in peer-reviewed journals is preferred.

• Advanced proficiency in R is required; experience with SAS is preferred.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.

• Employee assistance and family support programs, which include commuter benefits and tuition reimbursement.

• At least 120 hours of paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in line with company policy.

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan.

• The Employees’ Stock Purchase Plan (ESPP) provides eligible colleagues the chance to acquire company stock at a discounted rate.