Biostatistician Contractor

Position Description

We are seeking an experienced Contract Biostatistician to provide statistical leadership across clinical development, evidence generation, and scientific publication activities. This individual will play a key role in the design, analysis, interpretation, and communication of clinical and observational data, with particular emphasis on meta-analyses, external comparator analyses, evidence generation, and advanced statistical methodologies.

The ideal candidate will have a strong background working with clinical trial data while also bringing experience supporting Real-World Evidence (RWE) initiatives and Medical Affairs projects. This position will collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Health Economics & Outcomes Research (HEOR), Regulatory Affairs, and Commercial, to support strategic analyses that inform clinical development, publications, and scientific decision-making.

Responsibilities and Duties

• Provide statistical leadership for clinical development and evidence generation projects utilizing both clinical trial and real-world data.
• Provide statistical expertise in analyses involving external control arms, synthetic control methodologies, external comparator analyses, meta-analyses, and causal inference methods (e.g., propensity score matching, inverse probability weighting, and related methodologies).
• Lead or support evidence generation activities to address scientific, clinical, and strategic research questions.
• Partner with cross-functional teams to support scientific publications, including manuscripts, abstracts, posters, and conference presentations.
• Provide statistical support for publication strategy and execution.
• Contribute statistical expertise to Medical Affairs and Real-World Evidence initiatives, as appropriate.
• Collaborate with Clinical Development teams on study design, protocol review, endpoint selection, and statistical methodology.
• Develop Statistical Analysis Plans (SAPs), TLF shells, and review programming specifications.
• Work closely with statistical programmers to conduct analyses, review programming deliverables, and ensure the quality and accuracy of statistical outputs.
• Perform statistical programming for advanced analyses, as needed.
• Review relevant medical and scientific literature to support evidence generation strategies and methodological approaches.
• Ensure all statistical analyses are conducted with scientific rigor and in accordance with applicable regulatory requirements and industry standards.

Minimum Requirements

Experience

• M.S. or Ph.D. in Biostatistics (or equivalent) with 5+ years of pharmaceutical, biotechnology, or related industry experience.
• Strong experience analyzing and interpreting clinical trial data across multiple phases of drug development.
• Experience supporting evidence generation through advanced statistical methodologies.
• Demonstrated expertise conducting meta-analyses, external comparator analyses, indirect treatment comparisons, pooled analyses, and causal inference analyses.
• Experience working with Real-World Evidence (RWE) datasets and supporting Medical Affairs initiatives is preferred.
• Experience supporting scientific publications, including manuscripts, abstracts, and conference presentations.

Other Qualifications

• Strong understanding of advanced statistical methodologies and evidence synthesis techniques.
• Familiarity with regulatory expectations related to clinical research; knowledge of RWE and HTA guidance is a plus.
• Excellent statistical reasoning, analytical problem-solving, and scientific communication skills.
• Ability to effectively communicate complex statistical concepts to cross-functional stakeholders.
• Strong statistical programming skills using SAS, R, or other relevant statistical software.
• Experience writing Statistical Analysis Plans (SAPs) and developing TLF specifications.
• High attention to detail and commitment to methodological rigor and data quality.
• Ability to work independently in a fast-paced, collaborative environment.
• Solid understanding of Good Clinical Practice (GCP) guidelines.
• Oncology experience preferred.