Doctoral degree (e.g. PhD, MD, ScD, PharmD) in Epidemiology or related discipline with 8+ years of experience
Master’s degree (e.g. MSc) in Epidemiology or related discipline with 10+ years of experience
Deep understanding of observational study design and causal inference
Strong technical reading, writing, and communication skills
Requirements:
Provide strategic, scientific, and operational support for real-world evidence generation across the product lifecycle
Serve as the accountable scientific owner for high impact RWE studies
Lead RWE in scientific forums and collaborate with external partners
Provide end to end support for RWE studies, including design, protocol development, and analysis
Job description
Our client, is a Biopharmaceutical company, is looking for a Senior Analyst – III for their Remote location.
Responsibilities:
As Contractor, Real-World Evidence, you will provide strategic, scientific, and operational support for real-world evidence generation across the product lifecycle, with a core focus on the design and execution of external control arms (ECAs) and other complex observational studies.
This role is central to Kite’s ability to contextualize single-arm trials and evolving treatment landscapes, support access, and strengthen evidence packages for innovative cell therapies.
Serves as the accountable scientific owner for high impact RWE studies intended to inform regulatory, HTA, payer, and clinical decision making.
Serve as a leader of RWE in scientific forums, and collaborate with external physicians, scientists, and researchers, as well as alliance partners, on RWE activities.
Provide strategic and scientific support for the design, execution, and communication of real world evidence across the product lifecycle.
Responsible for ensuring RWE is fit for purpose for regulatory, HTA, payer, and clinical decision making.
Provide end to end support for RWE studies, including, study design, protocol and SAP development, data source selection and feasibility, vendor oversight and quality control, analysis, interpretation, reporting, and financial stewardship.
Provide RWE expertise and input for regulatory filings (e.g. MAA, BLA, sBLA) as well as response to questions from regulatory authorities and HTA agencies.
Proactively identify opportunities where RWE can address key clinical or access uncertainties.
Engage with external collaborators, registries, academic partners, and data vendors.
Mentor and train team members on RWE methodology and analytics.
Ensure scientific rigor, transparency, and reproducibility consistent with internal RWE standard.
Requirements:
Doctoral degree (e.g. PhD, MD, ScD, PharmD) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8+ years of relevant, post-graduation experience with doctoral training OR
Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution with 10+ years of relevant experience with Master’s training
Deep understanding of observational study design and causal inference, real world data sources (claims, EHR, registries), bias, confounding, and sensitivity analyses.
Strong technical reading, writing and communication skills
Prior corporate experience in hematology/oncology therapeutic area is highly preferred
Preferred: minimum of four (4) years of professional experience in the biopharmaceutical industry
