Turning real-world data into evidence that drives life‑changing decisions.
R&D Partners is seeking a Senior Manager - Real-World Evidence Generation to support observational research studies and evidence generation initiatives within the biotech industry. This role involves cross‑functional collaboration to develop and execute real‑world evidence (RWE) strategies and studies, contributing to regulatory, payer, and clinical objectives.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities
* Develop and execute study concepts for incidence, prevalence, burden of illness, and natural history of disease assessments.
* Provide tactical support for RWE development, including registries and burden‑of‑illness studies for regulators, payers, and clinicians.
* Contribute to the development of RWE historical controls and methodologies.
* Adapt performance metrics and dashboards for RWE projects within the therapeutic area.
* Translate observational research methods and results into actionable insights for diverse audiences.
* Manage internal and external stakeholder expectations regarding strategic objectives and research execution.
* Write protocols, statistical analysis plans (SAPs), and clinical study reports; review study documents.
* Provide clinical expertise for regulatory filings and respond to regulatory authority inquiries.
* Collaborate with clinical investigators, thought leaders, advisory boards, and patient advocacy groups.
Key Skills and Requirements
Basic Qualifications
* Scientific degree (MSc, PhD, MD, or PharmD) with experience in biostatistics, epidemiology, health economics, or outcomes research.
Preferred Qualifications
* PhD in biostatistics, epidemiology, health economics, outcomes research, or health policy.
* Experience in hematology and/or oncology.
* Expertise in post‑marketing authorization studies (PAS/PMAS).
* Formal training in epidemiology or health services research.
* Significant experience in observational research study management and data analytics (industry or consulting).
* Proficiency in conducting/reviewing systematic literature reviews.
* Advanced knowledge of observational research design.
* Strong interpersonal communication and study management skills.
* Ability to translate detailed observational study results into clear, non‑technical language for cross‑functional teams.
* Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).
* Experience with statistical software (e.g., R, SAS, SPSS, Stata).
For more information, please contact Seb Rose.
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