ClinChoice - Principal Biostatistician Consultant - Remote (experience working with medical affairs and commercial)

Remote - United States1w ago

Remote Principal NA Pharmaceuticals Biotechnology Principal Remote Assistant Performance Reviews Data Quality

Requirements

• M.S., Biostatistics or Ph.D. in Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology, or equivalent experience. • Other: • 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 • #LI-TT1 #LI-Remote #Principal#Contract

Responsibilities

• 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