M.S. or Ph.D. in Biostatistics or related field with 5+ years industry experience.
Experience in pharmaceutical, biotechnology, or healthcare sectors.
Familiarity with Medical Affairs and HEOR functions in life sciences.
Understanding of observational research and causal inference methodologies.
Proficiency in SAS, R, or similar statistical programming software.
Strong communication skills for conveying statistical concepts to non-experts.
Experience in oncology or similar complex therapeutic areas is a plus.
Responsibilities
Partner with Medical Affairs to support publication strategies.
Collaborate with HEOR teams for statistical input on economic models.
Provide statistical expertise for a variety of research methodologies.
Contribute to scientific manuscripts and presentations.
Ensure analyses meet HTA expectations and payer requirements.
Review protocols for real-world evidence studies with a statistical lens.
Conduct ad hoc analyses and quality review of statistical outputs.
Develop statistical analysis plans and study documentation efficiently.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity for professional growth in a specialized area of research.
Engagement with state-of-the-art methodologies and research techniques.
Access to training and resources for skill enhancement.
Focus on impactful projects in healthcare and pharmaceutical development.
Full Job Description
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.
