Commercial - Real World Evidence Scientist

Real World Evidence Scientist

CSL Seqirus 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

Reason for Request:
Current team member going on paternity leave end of March

Interview Process:

• 1st round with Hiring Manager
• 2nd round with additional Team Member
• Potential for 3rd round with Management (if needed)

EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."