Biostatistician Contractor
Key Responsibilities
- Partner with Medical Affairs to support publication strategies and evidence-generation initiatives.
- Collaborate with HEOR teams to provide statistical input for economic models and outcomes research analyses.
- Provide statistical expertise for observational research, external and synthetic control analyses, meta-analyses, and causal inference methodologies, including propensity score-based approaches.
- Contribute to scientific manuscripts, abstracts, posters, presentations, and other evidence dissemination activities.
- Collaborate with HEOR stakeholders to ensure analyses align with health technology assessment (HTA) expectations and payer evidence requirements.
- Review and provide statistical input on protocols for real-world evidence studies.
- Partner with statistical programmers to conduct ad hoc analyses and perform quality review of statistical outputs.
- Perform statistical programming for advanced analytical methods and support quality control of programming deliverables.
- Review relevant scientific and medical literature to inform study design and analysis strategies.
- Develop statistical analysis plans (SAPs) and related study documentation.
- Create table, listing, and figure (TLF) shells and review programming specifications.
Qualifications
Education & Experience
- M.S. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 5 years of pharmaceutical, biotechnology, healthcare, or related industry experience; or
- Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with relevant industry experience.
Preferred Skills & Expertise
- Experience supporting Medical Affairs, HEOR, or evidence-generation functions within the life sciences industry.
- Strong understanding of observational research methodologies, meta-analysis techniques, and causal inference approaches.
- Familiarity with regulatory and industry guidance related to real-world evidence and health technology assessment requirements.
- Strong statistical reasoning, analytical problem-solving, and study design capabilities.
- Ability to effectively communicate complex statistical concepts to non-statistical audiences.
- Demonstrated commitment to methodological rigor and data quality.
- Ability to work independently and manage multiple priorities in a fast-paced, cross-functional environment.
- Understanding of Good Clinical Practice (GCP) guidelines and applicable industry standards.
- Proficiency with statistical programming software such as SAS, R, or equivalent platforms.
- Experience in oncology or other complex therapeutic areas is preferred.
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