Associate Director – Biostatistics

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

📋 Description

• Execute statistical research tasks involving moderate to high levels of technical complexity, with a focus on patient-reported outcomes and various clinical outcome assessments in both clinical trials and real-world data.

• Plan, implement, and document statistical analyses for clinical trials and observational studies.

• Create statistical analysis plans ranging from simple to moderately complex and assist in the development of more advanced SAPs under guidance.

• Compose the statistical sections of study reports, protocols, and proposals.

• Ensure the quality, accuracy, and punctuality of statistical analyses and programming outputs.

• Offer statistical and methodological solutions to internal, cross-functional project teams.

• Mentor and supervise less experienced staff on specific project tasks.

• Acquire and apply new statistical techniques in response to changing project and research requirements.

• Contribute to the scientific reputation and professional growth of the biostatistics team.

• Prepare presentations for external stakeholders.

• Lead proposal development with limited supervision while closely collaborating with multidisciplinary project teams.

⛳️ Requirements

• Master's degree with a minimum of 6 years of experience, a PhD with at least 1 year of experience, or an equivalent combination of education and experience.

• Proven programming skills in SAS, including experience in developing reproducible analysis pipelines.

• Demonstrated experience in analyzing patient-reported outcome data within clinical trials, including its application to the estimand framework.

• Background in biostatistics or related quantitative fields.

• Understanding of Good Clinical Practice (GCP), quality assurance principles, and regulatory environments.

• Strong analytical, organizational, and problem-solving abilities.

• Excellent written and verbal communication skills.

• Capacity to manage multiple tasks, adhere to timelines, and work effectively in collaborative team settings.

• Preferred: Experience in the pharmaceutical sector.

• Preferred: Experience interacting with regulatory bodies, including the FDA, EMA, or other global health authorities.

• Preferred: Familiarity with R, machine learning, and natural language processing.

• Preferred: Experience with causal inference methods, such as propensity score methods, weighting, marginal structural models, and external control arm studies.

🏝️ Benefits

• Competitive base salary.

• Generous paid time off policy.

• Merit-based annual increases.

• Bonus opportunities.

• Robust recognition program.

• Competitive insurance plans, including health, dental, life, and short-term and long-term disability.

• Retirement savings program, such as a 401(k) plan.

• Paid parental leave for all parents.

• Financial assistance for adoption expenses or infertility treatments.

• Financial reimbursement for education and developmental opportunities.

• Employee assistance program.

• Additional offerings to support a healthy work-life balance.