Biostatistician – Medical Affairs & Real-World Evidence

Now Hiring: Biostatistician – Medical Affairs & Real-World Evidence (Remote)

Location: Remote (U.S.-Based Preferred)

Employment Type: Full-Time Contract

Are you a highly skilled Biostatistician with a passion for Real-World Evidence (RWE), Medical Affairs, and evidence generation? We are seeking an experienced Contract Biostatistician to provide statistical leadership across Medical Affairs, Health Economics & Outcomes Research (HEOR), and post-marketing evidence development initiative. This is an exciting opportunity to work at the intersection of science, data, and healthcare strategy, collaborating with cross-functional teams to generate meaningful evidence that informs clinical practice, payer decisions, and future research.

Position Overview:

The Biostatistician will play a critical role in the design, analysis, interpretation, and communication of Real-World Evidence and observational research studies. The successful candidate will provide statistical expertise for external comparator analyses, causal inference methodologies, meta-analyses, and post-marketing evidence generation activities supporting Medical Affairs, HEOR, Clinical Development, and Commercial teams.

Key Responsibilities:

• Statistical Leadership & Evidence Generation
• Provide statistical expertise for Real-World Evidence (RWE), observational studies, and external comparator analyses.
• Support evidence generation strategies for post-marketing research, payer evidence, and hypothesis-generating analyses.
• Design and review study protocols for real-world evidence research.
• Develop and author Statistical Analysis Plans (SAPs).
• Create and review Tables, Listings, and Figures (TLF) shells and programming specifications.
• Advanced Analytics

Lead analyses utilizing:

• External control and synthetic control methodolo
• giesMeta-analyses
• Causal inference methods
• Propensity score matching and related techniques
• Perform advanced statistical programming and support quality control activities.
• Collaborate with statistical programmers to execute ad hoc analyses and validate outputs.
• Cross-Functional Collaboration
• Partner closely with Medical Affairs on publication strategies and evidence dissemination.
• Collaborate with HEOR teams to support economic models and align analyses with Health Technology Assessment (HTA) expectations.
• Work with Clinical Development, Commercial, and Medical teams to ensure scientific and strategic alignment.

Scientific Communications

• Contribute to:
• Manuscripts
• Scientific abstracts
• Conference presentations
• Publications
• Review and synthesize relevant scientific and medical literature.
• Communicate complex statistical methodologies and findings to both technical and non-technical audiences.

Required Qualifications

• Education
• M.S. in Biostatistics, Statistics, or related quantitative discipline, or Ph.D. in Biostatistics, Statistics, or equivalent field

• Experience
• Minimum 5 years of experience within the pharmaceutical, biotechnology, CRO, or related healthcare industry.
• Experience supporting Medical Affairs and evidence generation initiatives.
• Strong knowledge of observational research and Real-World Evidence methodologies.

Technical Expertise

• Strong understanding of:
• Meta-analysis methodologies
• Causal inference techniques
• Propensity score methods
• External and synthetic control analyses
• Experience developing Statistical Analysis Plans (SAPs).
• Strong statistical programming skills using industry-standard software (e.g., SAS, R, or equivalent).
• Understanding of Good Clinical Practice (GCP) guidelines.

Preferred Qualifications

• Oncology experience strongly preferred.
• Experience supporting Health Economics & Outcomes Research (HEOR)

Familiarity with:

• FDA guidance on Real-World Evidence
• Health Technology Assessment (HTA) requirements
• Regulatory and payer evidence-generation strategies
• Experience collaborating with Commercial teams.

Key Competencies

✔ Strong statistical reasoning and analytical problem-solving skills

✔ Exceptional attention to detail and commitment to methodological rigor

✔ Ability to translate complex statistical concepts into actionable insights

✔ Excellent written and verbal communication skills

✔ Ability to work independently in a fast-paced, collaborative environment

✔ Strong cross-functional partnership and stakeholder management skills

Why Consider This Opportunity?

• 100% Remote Position
• Work on cutting-edge Real-World Evidence and Medical Affairs initiatives
• Collaborate with industry-leading scientific, medical, and HEOR teams
• Contribute to evidence that influences patient care, payer decisions, and future research
• Opportunity to apply advanced statistical methodologies to meaningful healthcare challenges.