Lead Biostatistician - PV Focus

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

📋 Description

• Lead the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-oriented observational studies utilizing intricate longitudinal registry data.

• Collaborate with researchers, epidemiologists, clinicians, and clients to formulate protocols, Statistical Analysis Plans (SAPs), and analytical strategies that align with client objectives and regulatory requirements.

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

• Provide strategic statistical leadership while making independent decisions related to safety analyses and the generation of real-world evidence.

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

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

⛳️ Requirements

• A Master’s degree in Biostatistics, Statistics, or Mathematics is required; a PhD is preferred.

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

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

• Experience with intricate longitudinal registry or real-world data is essential.

• Familiarity with retrospective and prospective observational study designs and associated methodologies is necessary.

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

• Leadership experience in pharmacovigilance or safety-centered analysis projects is preferred.

• Strongly preferred experience with causal inference theory and methods.

• Background in supporting regulatory safety studies, post-authorization safety studies (PASS), or related pharmacovigilance activities is preferred.

• Experience in mentoring or supervising junior biostatisticians is preferred.

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

• A solid understanding of statistical methodology for observational and longitudinal data analyses is important.

• Ability to independently lead projects, prioritize competing deliverables, and manage multiple timelines is essential.

• Strong scientific, analytical, problem-solving, leadership, and communication skills are necessary.

• Capacity to collaborate with cross-functional teams and convey complex statistical concepts to both technical and non-technical audiences.

• Strong attention to detail with a commitment to producing high-quality, reproducible analyses and documentation.

• Excellent written communication skills and adherence to best practices for statistical programming and code documentation are required.

• Ability to make independent decisions with limited supervision is essential.

• Strong interpersonal skills with a focus on collaboration within a team-oriented setting.

• Must be legally authorized to work in the United States without sponsorship.

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

🏝️ Benefits

• Opportunity to work remotely from home.

• Reasonable accommodations for disabilities during the application, interview, and employment processes.

• No relocation benefits are offered.