RWE Lead

Remote • Posted 17 hours ago • Updated 17 hours ago
Contract Independent
Contract W2
12 Months
No Travel Required
Remote
90+
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Job Details

Skills

  • Science

Summary

RWE Lead

Remote Role

12+ Months

 

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we''re not finished yet. Join Client, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

 

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 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

 

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10494738
  • Position Id: 8985476
  • Posted 17 hours ago

Company Info

About Fynbosys Inc

Fynbosys is a leading software & services company in California, and is headquartered in Sacramento. Our company's philosophy is to Develop the Future and we are known for anticipating and responding rapidly to our customer's present and future needs. Fynbosys is a software development company and we develop software solutions along with applications and management solutions, as well as support, training, and consulting services to customers

Our complete spectrum of professional management and engineering services ensures the successful definition, execution, and completion of mission-critical programs. We bring the requisite subject matter expertise to support our customers with their systems, software engineering, sales management system, document imaging and digitization system and training needs.

We are your industries partner, we know your business, and it's our business to help you succeed at yours. For the past few years, we've been doing just this and as a result, we've built enduring relationships with all our Clients.

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Kavin Prasanth

Kavin Prasanth

Recruiter @ Fynbosys Inc
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