Director RWE Biostatistics

EPM Scientific; Ohio; On-site; USD 160,000 - 240,000; Full time

Job summary

EPM Scientific is seeking a Director of Biostatistics specializing in Real World Data to lead strategic initiatives in the analysis and interpretation of real-world evidence. This role involves collaboration across clinical, regulatory, and commercial teams to enhance patient outcomes and support innovative medical devices. The ideal candidate will possess extensive experience in biostatistics, particularly in RWD/RWE, and will be responsible for shaping the company's RWD strategy while mentoring a high-performing team.

Qualifications

• 10+ years of experience in biostatistics, with at least 5 years focused on RWD/RWE.
• Strong understanding of regulatory requirements related to RWE.
• Proven experience with large healthcare databases.

Responsibilities

• Lead RWD strategy and develop biostatistics strategy for RWD initiatives.
• Provide statistical leadership in the design and analysis of observational studies.
• Collaborate with regulatory affairs to support submissions.

Skills

Statistical software

Leadership

Project management

Communication

Interpersonal skills

Education

PhD or Master's degree in Biostatistics, Statistics, Epidemiology

Tools

SAS

R

Python

Job description

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Base pay range

$160,000.00/yr - $240,000.00/yr

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We have a current opportunity for a Director RWE Biostatistics on a permanent basis. The position will be based in Wayne. For further information about this position, please apply.

Job Title: Director, Biostatistics - Real World Data (RWD)

Department: Clinical & Data Sciences

Position Summary:

We are seeking a strategic and experienced Director of Biostatistics - Real World Data (RWD) to lead the design, analysis, and interpretation of real-world evidence (RWE) to support the development, regulatory approval, and post-market surveillance of our innovative medical devices. This role will be instrumental in shaping our RWD strategy, collaborating cross-functionally with clinical, regulatory, data science, and commercial teams to drive data-driven decision-making and improve patient outcomes.

Key Responsibilities:

• Lead RWD Strategy: Develop and execute the biostatistics strategy for RWD initiatives aligned with corporate and regulatory goals.
• Study Design & Analysis: Provide statistical leadership in the design and analysis of observational studies, registries, claims databases, and electronic health records (EHRs).
• Regulatory Support: Collaborate with regulatory affairs to support submissions and interactions with global health authorities, including FDA, EMA, and others.
• Cross-functional Collaboration: Partner with clinical, epidemiology, HEOR, data science, and commercial teams to generate actionable insights from RWD.
• Methodological Innovation: Stay current with and apply advanced statistical methodologies including causal inference, propensity score matching, and machine learning techniques.
• Team Leadership: Build and mentor a high-performing team of biostatisticians and data analysts.
• Vendor Oversight: Manage external vendors and CROs to ensure quality and timely delivery of statistical outputs.
• Publications & Presentations: Contribute to scientific publications and represent the company at conferences and industry forums.

Qualifications:

• PhD or Master's degree in Biostatistics, Statistics, Epidemiology, or related field.
• 10+ years of experience in biostatistics, with at least 5 years focused on RWD/RWE in the life sciences industry.
• Strong understanding of regulatory requirements and guidance related to RWE (e.g., FDA RWE Framework, EMA guidance).
• Proven experience with statistical software (e.g., SAS, R, Python) and large healthcare databases.
• Demonstrated leadership and project management skills.
• Excellent communication and interpersonal skills.

Preferred Qualifications:

• Experience in the medical device industry or with combination products.
• Familiarity with digital health technologies and connected devices.
• Experience with global regulatory submissions involving RWD.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing

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