Associate Director-Biostatistics

About The Role

RTI Health Solutions (RTI-HS) is a subsidiary of RTI International, offering healthcare consulting and research expertise globally. We specialize in optimizing decision-making for pharmaceutical, biotech, and medical device products throughout their development and market phases. Our practice areas include Value, Access, and HEOR; Patient-Centered and Outcomes Research; Epidemiology and Biostatistics; Medical Communications; Global Business Operations; and Strategic Consulting and Growth.

What You'll Do

• Plan, conduct, and document statistical analyses for clinical trials and observational studies, focusing on patient-reported outcomes and clinical outcome assessments.
• Develop simple to moderately complex statistical analysis plans and contribute to more complex SAPs under supervision.
• Write statistical sections of study reports, protocols, and proposals.
• Ensure the quality, accuracy, and timeliness of statistical analyses and programming outputs.
• Provide statistical and methodological solutions to internal, cross-functional project teams.
• Mentor and oversee less experienced staff on selected project tasks.
• Learn and apply new statistical methods in response to evolving project and research needs.
• Contribute to the scientific reputation and professional development of the biostatistics group and prepare presentations for external audiences.

What You'll Need

• A Master's degree and at least 6 years of experience, or a PhD and at least 1 year of experience, or equivalent combination of education and experience.
• Demonstrated programming skills in SAS, including experience developing reproducible analysis pipelines.
• Demonstrated experience analyzing patient-reported outcome data in clinical trials, including application to the estimand framework.
• Background in biostatistics or related quantitative disciplines.
• Knowledge of Good Clinical Practice (GCP), quality assurance principles, and regulatory environments.

Preferred Experience

• Experience in the pharmaceutical industry.
• Experience interacting with regulatory agencies, including FDA, EMA, or other global health authorities.
• Familiarity with R, machine learning, and natural language processing.
• Experience with causal inference methods (e.g., propensity score methods, weighting, marginal structural models) and external control arms studies.

Qualifications

• Master's degree and at least 6 years of experience, PhD and at least 1 years of experience, or equivalent combination of education and experience.
• Demonstrated programming skills in SAS, including experience developing reproducible analysis pipelines.
• Demonstrated experience analyzing patient-reported outcome data in clinical trials including application to the estimand framework.
• Background in biostatistics or related quantitative disciplines.
• Knowledge of Good Clinical Practice (GCP), quality assurance principles, and regulatory environments.

Benefits

• Competitive base salary.
• Generous paid time off policy.
• Merit-based annual increases.
• Bonus opportunities.
• Total rewards package including health, dental, life, and short-term and long-term disability insurance.
• Retirement savings program.
• Paid parental leave for all parents.
• Financial assistance with adoption expenses or infertility treatments.
• Financial reimbursement for education and developmental opportunities.
• Employee Assistance Program.

Pay Range

The anticipated pay range for this role is $110,000.00 - $130,000.00.