Principal Biostatistician Consultant – Medical Affairs, Commercial

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

📋 Description

• Collaborate with the medical team to develop publication strategies, including HEOR or economic modeling contributions.

• Offer statistical expertise in analyses involving external control and/or synthetic control, meta-analyses, and causal inference analyses, such as propensity score matching methods.

• Assist in the preparation of manuscripts, abstracts, and presentations.

• Work alongside HEOR to ensure analyses meet HTA agency requirements.

• Evaluate protocols for real-world evidence studies.

• Partner with statistical programmers to perform ad hoc analyses and conduct quality reviews of statistical analyses.

• Execute statistical programming for advanced methodologies and support statistical programmers in quality control of their programs.

• Analyze relevant medical literature.

• Draft statistical analysis plans.

• Create TLF shells and review programming specifications.

⛳️ Requirements

• M.S. in Biostatistics or Ph.D. in Biostatistics or a related field, with a minimum of 5 years of experience in the pharmaceutical, biotechnology, or a similar industry.

• Previous experience in medical affairs and commercial sectors.

• Strong understanding of meta-analyses and causal inference methodologies.

• Knowledge of regulatory guidelines pertaining to RWE and HTA requirements.

• Exceptional statistical reasoning and problem-solving abilities.

• Capability to convey complex methodologies to non-statistical stakeholders.

• Keen attention to data quality and methodological integrity.

• Ability to work autonomously in a dynamic, cross-functional setting.

• Familiarity with good clinical practice guidelines.

• Proficient in statistical programming using relevant statistical software.

• Experience in oncology is preferred.

🏝️ Benefits

• Health insurance.

• Opportunities for professional development.