Job Title

RWE (Real-World Evidence) SpecialistUK - remote based Job Description: We are seeking a highly skilled and motivated RWE Specialist to join our dynamic team. This role is pivotal in the development and execution of studies assessing disease incidence, prevalence, burden of illness, and natural history of disease. You will support both business and early development indications through strategic and tactical approaches to Real-World Evidence (RWE) generation and application.Key Responsibilities:Lead study concept development and execution for RWE studies, focusing on disease incidence, prevalence, burden of illness, and natural history of disease.Provide tactical support for cross-functional RWE development, including registries and assessments for regulators, payers, and clinicians.Contribute to the strategic and tactical development of historical control methods and RWE methodologies.Adapt performance metrics and dashboards for RWE projects within therapeutic areas.Effectively communicate complex observational research methods and findings to diverse audiences, ensuring clarity and understanding.Manage internal and external stakeholder expectations related to research objectives and execution.Draft and review study protocols, statistical analysis plans (SAPs), clinical study reports, and other study-related documents.Provide clinical expertise for regulatory filings, responding to questions from regulatory authorities, including IND submissions and clinical trial applications.Collaborate with clinical investigators and thought leaders in the field.Lead and contribute to interactions with external stakeholders such as medical experts, advisory boards, and patient advocacy groups, as well as internal teams in Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial departments.Basic Qualifications:A 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, health policy, or related fields.Experience in Hematology and/or Oncology.Formal training in Epidemiology/Health Services Research.Extensive experience in observational research study management and data analytics, either within the industry or with an observational research consulting firm.Expertise in conducting and reviewing systematic literature reviews.Advanced knowledge of observational research design and methodologies.Exceptional interpersonal communication and study management skills.Ability to translate complex observational research results into clear, non-technical language for internal cross-functional teams, while preserving key findings.Ability to thrive in a fast-paced, diverse, and matrixed environment.Proficiency in the Microsoft Office Suite (Word, PowerPoint, Excel).Proficiency in statistical software (e.g., R, SAS, SPSS, or Stata) for data analysis.About Planet Pharma:Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.