Jobs

Description

Remote Role

Job Description:

• 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 Client’s ability to contextualize single-arm trials and evolving treatment landscapes, support access, and strengthen evidence packages for innovative cell therapies.
• This role, also, serves as the accountable scientific owner for high impact RWE studies intended to inform regulatory, HTA, payer, and clinical decision making.
• You may also 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.

Additional Responsibilities

• Provide strategic and scientific support for the design, execution, and communication of real world evidence (RWE) 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.

Qualifications:

• 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