Senior Advisor, Statistics

Location: Indianapolis, Indiana, United States

Full Time

The Senior Advisor - Statistics will provide advanced statistical leadership for the design, analysis, and interpretation of clinical studies. This role will directly support clinical research scientists, physicians, and data teams in developing study protocols, data analysis plans, and regulatory submissions.

The ideal candidate will have deep expertise in statistical methods, clinical trial design, and regulatory compliance, as well as proficiency in modern programming tools such as SAS and R.

• Provide input into clinical study protocols and develop statistical analysis plans.
• Select and justify appropriate statistical methods for clinical trials and other studies.
• Collaborate with data sciences to implement data quality assurance and validation processes.
• Conduct complex statistical analyses and contribute to database design for reporting.
• Perform peer reviews of statistical deliverables from team members.
• Communicate statistical findings and interpretations to physicians, scientists, and regulatory authorities.
• Prepare data summaries, tables, and visualizations for internal and external presentations.
• Contribute to manuscripts, white papers, and regulatory documentation (NDA, BLA submissions).
• Maintain up-to-date understanding of disease areas, study endpoints, and evolving regulatory standards.
• Partner with cross-functional clinical teams to ensure compliance with GCP, FDA, and ICH guidelines.
• Introduce and apply innovative methodologies, such as Bayesian models or adaptive trial designs.
• Merge statistical rigor with strategic business acumen to inform decision‑making.
• Mentor junior statisticians and promote best practices across study teams.

• Ph.D. in Statistics or Biostatistics.
• Minimum 3 years of experience in clinical research and development (preferably in the pharmaceutical or biotech sector).
• Proficiency with SAS, R, Spotfire, WinBUGS or similar tools.
• Strong understanding of clinical trial design, data management, and regulatory compliance.
• Excellent interpersonal and communication skills, with ability to present to diverse audiences.
• Experience in a large, matrixed healthcare or biotech organization.
• Demonstrated success in cross‑functional leadership and regulatory submissions.
• Familiarity with adaptive trial designs, Bayesian statistics, or machine learning in clinical data.
• Strong problem‑solving, analytical thinking, and time‑management skills.