Associate Director RWE Science
Commercial Metals
US
Remote
22 days ago
Job Description
Associate Director RWE Science Assignment Length: 7 months (includes approximately 1 month ramp-up followed by 6 months coverage for paternity leave) Eastern Time business hours preferred; flexibility required due to a global team (EU collaboration is frequent) Location & Work Arrangements: • Candidates must be able to work onsite or hybrid initially at client's location in the eastern half of the United States • The hiring manager may approve a fully remote arrangement for the right candidate after an initial working period, once there is confidence in performance and collaboration • Because of this, candidates must be open to working onsite or hybrid initially Job Description: Client is seeking a highly experienced Real World Evidence (RWE) Scientist to provide temporary coverage for a team member on paternity leave. This is a senior, hands-on role for an epidemiologist or RWE professional who can quickly step in and assume ownership of ongoing Phase IV and post-approval real-world evidence studies. The assignment includes EU-facing activities (e.g., feasibility and evidence planning with a Europe focus). This role is an individual contributor position (no people management), but it requires strong independent leadership, sound scientific judgment, and the ability to work effectively in a matrixed Medical Affairs environment. Key Responsibilities: • Lead the design, execution, and analysis of real-world and observational research studies, ensuring methodological rigor and fit-for-purpose designs • Manage in-flight Phase IV and post-approval epidemiologic studies; oversee vendors/CROs to ensure quality and timely delivery • Conduct and oversee retrospective analyses using large real-world data sources (e.g., claims, EHRs, registries) • Contribute to the development of RWE plans and lead feasibility assessments with a focus on Europe (NITAG/regulatory awareness beneficial) • Support development of protocols for real-world studies and pragmatic trials, providing technical and methodological guidance to stakeholders • Perform evidence reviews and assessments to support strategic decision-making (e.g., submissions, reimbursement, medical strategy) • Support external communication and engagement related to RWE in collaboration with Regional Medical Affairs (e.g., forums, advisory, scientific exchange) • May include: conducting and reporting systematic literature reviews (SLR) and meta-analyses • Support scientific communication via internal readouts and external publications (abstracts, posters, manuscripts), as needed Required Qualifications: • Advanced degree (MD, PhD, or MS) in Epidemiology, Biostatistics, Public Health, or a closely related field • 8–10 years of progressive epidemiology or real-world evidence experience • At least 5 years of experience within Pharma or Biotech • Strong experience designing and leading both: – Prospective / Phase IV epidemiologic studies – Retrospective analyses using real-world data • Proficiency with statistical tools/software (e.g., SAS, R, Stata) and strong understanding of claims/EHR data structures • Ability to work independently and assume ownership of ongoing work with minimal ramp-up • Flexibility to participate in meetings outside of standard business hours due to a global team (EU and/or Australia) Preferred / Nice to Have Qualifications: • Experience supporting regulatory-/HTA-facing RWE deliverables, and/or post-approval commitments • Vaccines / infectious disease background • R programming skills, including ability to develop or enhance Shiny applications • Experience with data extraction, cleaning, and standardization for RWD analyses • Prior authorship of abstracts, manuscripts, or scientific presentations • Experience in a global, matrixed Medical Affairs environment and with vendor/CRO oversight Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 76.92/hr.