Lead Biostatistician – Pharmacovigilance

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

📋 Description

• Act as the statistical lead for prominent pharmacovigilance (PV) and safety-centric initiatives.

• Direct the statistical design, analysis, interpretation, and reporting of observational studies.

• Collaborate with investigators, epidemiologists, clinicians, and clients.

• Independently conduct advanced statistical analyses and perform sample size/power calculations.

• Provide strategic statistical guidance and make informed statistical decisions autonomously.

• Supervise and mentor Biostatistician I/II analysts and other junior personnel.

• Create and apply standardized methodologies and analytical templates.

⛳️ Requirements

• A PhD in Biostatistics, Statistics, or Mathematics is preferred.

• A master’s degree in the aforementioned fields is mandatory.

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

• Proven experience in leading complex observational research studies, equivalent to at least 3 years, is required.

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

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

• Must possess demonstrated knowledge of both retrospective and prospective observational study designs and related methodologies.

• Strongly preferred experience with causal inference theory and methods.

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

• Preferred experience in mentoring or supervising junior biostatisticians.

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

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

🏝️ Benefits

• This position does not provide relocation benefits.

• Must have legal authorization to work in the United States without sponsorship.

• Must successfully pass a comprehensive background check, including a drug screening.

• Contribute to accelerating life sciences research.

• Engage in solving complex analytical challenges.

• Enhance productivity in laboratories.