Principal Biostatistician Consultant – Medical Affairs, Commercial

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🇺🇸 United States – Remote

⏳ Contract/Temporary

🔴 Lead

🧪 Clinical Research

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 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