Senior Real World Evidence (RWE) Scientist - Oncology
Posted Today by Cube Hub, Inc.
Negotiable
Undetermined
Remote
Remote or Foster City, California
Summary: The Senior Real World Evidence (RWE) Scientist in Oncology will provide strategic and scientific support for real-world evidence generation throughout the product lifecycle, focusing on the design and execution of external control arms and complex observational studies. This role is crucial for contextualizing single-arm trials and informing regulatory and clinical decision-making. The position also involves collaboration with external partners and mentoring team members on RWE methodologies. The role is remote and spans a duration of 6 months.
Key Responsibilities:
- Provide strategic and scientific support for the design, execution, and communication of real-world evidence across the product lifecycle.
- Ensure 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) and respond to questions from regulatory authorities and HTA agencies.
- 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 standards.
Key Skills:
- Doctoral degree (e.g. PhD, MD, ScD, PharmD) in Epidemiology or related discipline, or Master's degree (e.g. MSc) in Epidemiology with relevant experience.
- 8+ years of relevant post-graduation experience with doctoral training or 10+ years with Master's training.
- Deep understanding of observational study design and causal inference, real-world data sources, bias, confounding, and sensitivity analyses.
- Strong technical reading, writing, and communication skills.
- Prior corporate experience in hematology/oncology therapeutic area is highly preferred.
- Minimum of four (4) years of professional experience in the biopharmaceutical industry preferred.
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Detailed Description From Employer:
Job Title: Senior Real World Evidence (RWE) Scientist Oncology
Remote Role
Job Duration: 6 months
Remote Role
Job Duration: 6 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. as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm.
But we're not finished yet. 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 ability to contextualize single-arm trials and evolving treatment landscapes, support access, and strengthen evidence packages for innovative cell therapies.
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 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.
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
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