Title: Senior Manager, Patient Experience Data & Strategy, Patient Centered Outcomes Research
Location: Remote
Duration: 12 months

Note: Experience in oncology is preferred but not required. Candidates with strong quantitative and statistical training from other therapeutic areas are encouraged to apply.

Purpose: The Senior Manager, Patient Experience Data & Strategy serves within the Patient-Centered Outcomes Research (PCOR) team to independently design and execute patient experience data (PED) strategies across oncology studies. The main objective is to optimize product registration, access & reimbursement through intentional and purposeful generation of PED across all phases of drug development in oncology. This is achieved by collaborating closely with HEOR, Clinical Development & Operations, Regulatory, and Commercial teams. Strong quantitative and statistical abilities are preferred for developing robust research plans, advanced statistical analysis plans, and conducting rigorous analyses of PRO and COA endpoints across oncology portfolios.

This role requires critical thinking to design and implement COA measurement strategies, ensuring these strategies are integrated into clinical development programs. Deep familiarity with psychometric and statistical methods for validating and analyzing COAs in clinical trials is expected (oncology experience preferred but not required). The Senior Manager will summarize complex PED analyses into clear communications for internal and external stakeholders, including regulatory submissions and scientific presentations. The ability to effectively interpret, present, and translate data-driven insights is crucial.

Responsibilities:
1. Conducts literature & landscape reviews to develop disease conceptual models focused on patient-centered outcomes in oncology.
2. Identifies & statistically evaluates existing COA tools, determining fit-for-purpose through rigorous quantitative analysis (with an emphasis on oncology when possible).
3. Leads development, validation, and integration of COA measurement strategy into clinical development, including protocol/SAP content development, advanced results interpretation, and reporting.
4. Designs and executes PED research using a variety of quantitative methods, including psychometric analyses (e.g., factor analysis, reliability/validity testing) and statistical programming for COA endpoint analysis in clinical trials (oncology experience is an advantage).
5. Develops high-level technical content for regulatory and reimbursement submissions, translating complex quantitative findings into reporting documents.
6. Drives strategic scientific communication, including data-rich publications and presentations at peer-reviewed journals and medical congresses (with focus on oncology when feasible).
7. Contributes to best practices for quantitative PED/COA analysis and provides education to internal stakeholders to advance the integration of the patient voice.
8. Manages high-quality publication processes, ensuring statistical rigor and scientific integrity in all communications.
Qualifications:
• Advanced degree (MS, MPH, PharmD, PhD) in Biostatistics, Epidemiology, HEOR, Public Health, or a related quantitative field.
• At least 3 years direct research experience with strong hands-on quantitative and statistical analysis in clinical trials and PRO/COA data (oncology experience preferred, but not required).
• Deep understanding of measurement science principles, advanced psychometric/statistical methods, and their application in clinical research.
• Proven experience developing and implementing statistical analysis plans (SAPs) for clinical outcomes (oncology expertise is an advantage).
• Ability to synthesize complex quantitative healthcare data into actionable insights for various stakeholders, including regulatory audiences.
• Strong project management and communication skills, with a track record of collaboration across multifunctional teams in a clinical or healthcare environment.
• Familiarity with clinical trial design, industry compliance standards, and requirements for regulatory documentation regarding COA endpoints.
• Demonstrated initiative, strong work ethic, and the ability to manage multiple projects with competing priorities in a fast-paced environment. 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.