Director RWE Biostatistics

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 combination products.
• Familiarity with digital health technologies and connected devices.
• Experience with global regulatory submissions involving RWD.