Principal Biostatistician Consultant – Medical Affairs, Commercial

Job Description:

• Partner with medical for publication strategies, HEOR or economic modeling inputs
• Provide statistical expertise in analyses using external control and/or synthetic control, meta-analyses, and causal inference analyses, e.g. propensity score matching method
• Contribute to manuscripts, abstracts and presentations
• Collaborate with HEOR to align analyses with HTA agency expectations
• Review protocols for real world evidence studies
• Work with statistical programmers to conduct ad hoc analyses; Conduct quality review of statistical analyses
• Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
• Review relevant medical literature
• Write statistical analysis plans
• Develop TLF shells and review programming specs

Requirements:

• M.S., Biostatistics or Ph.D. in Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience.
• Prior experience working with medical affairs and commercial
• Good understanding of meta-analyses and causal inference methodologies
• Familiarity with regulatory guidance on RWE and HTA requirements
• Strong statistical reasoning and problem-solving
• Ability to communicate complex methods to non-statistical stakeholders
• High attention to data quality and methodological rigor
• Ability to work independently in a fast-paced, cross-functional environment
• Understand good clinical practice guidelines
• Good statistical programming skills using relevant statistical software
• Oncology experience preferred.

Benefits:

• Health insurance
• Professional development opportunities