M
Commercial - Real World Evidence Scientist
Mindlance
🇺🇸 United States
Remote
Manager or above
7 months ago
- EHR
- SAS
- Stata
7 months ago
Preferred Job Title: Associate Director RWE Science
Quantity Needed: 1
Assignment Length: 7 months (includes approximately 1 month ramp-up followed by 6 months coverage for paternity leave)
Schedule:
• Full-time (40 hours/week)
• Eastern Time business hours preferred; flexibility required due to a global team (EU collaboration is frequent)
Start: Targeting beginning of March to allow time for knowledge transfer, training, etc.
Location & Work Arrangements:
• Candidates must be able to work onsite or hybrid initially at a CSL or Seqirus 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
Hourly Bill Rate:
Job Description:
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)
FTE Conversion Potential: Possible but unlikely in US market
Spotlight call to be scheduled following full request approval; call details will be shared with suppliers via Beeline notes.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Commercial - Real World Evidence Scientist · Mindlance