Sr. Manager of Statistical Programming Overview: Looking for a hands-on Sr. Manager of Statistical Programming to provide statistical programming support to clinical trials for regulatory...
Associate Director of HEOR
· Develop HEOR strategies for inline psychiatry brands and/or pipeline products through cross functional, internal collaboration and alignment as well as through external collaboration with lead HE/OR researchers and decision-makers.
Participate as an integral member of the medical/commercial brand team for inline or pipeline products.
Develop and implement appropriate HEOR brand/product tactics to assist the development of promotional and/or payor claims that support market positioning and enhance market access.
Conceptualize, implement and manage HEOR projects from inception to completion for all phases of research, including publication, dissemination, and presentation.
Set milestones and manage external vendors and HEOR consultants for timely project deliverables.
Provide robust HEOR tactical input into PhII-PhIV clinical trials including research design, appropriate choice of HEOR endpoints, data collection methods, data analysis and interpretation through collaboration with Clinical Development and Medical Affairs.
Design and oversee strategies to obtain regulatory approval of PRO (health-related quality of life) claims.
Research and select PRO/HRQOL measures for use in clinical trials.
Draft, edit, and finalize the creation of HEOR section of PDP, protocol concept documents, clinical study protocols, analysis plans, and final study reports for NDA/sNDA submissions as needed.
Develop HEOR manuscripts from data obtained from clinical studies that included health economics and PRO components.
Collaborate with the Field HEOR team to ensure that HEOR economic models and payor tools/dossiers demonstrate value from a payer perspective to support pricing defense, reimbursement and market access and utilization goals.
Develop health economic analyses or economic models to assess cost-effectiveness, clinical practice, and/or burden of illness using a combination data from internal clinical trials and external primary or secondary data sources.
Contribute to the development of value/AMCP dossier for submission to formulary committee and collaborate with Medical Information for periodic dossier updates.
Develop a comprehensive and compelling HEOR publication strategy, in alignment with the scientific communication strategy to appropriately disseminate the generated HEOR evidence.
Assist in the development and establishment of processes and procedures to maximize HEOR operational excellence within brands/product lines of responsibility. (e.g.: HEOR standard operating procedures for prospective, database, and other modeling studies; vendor validation procedures, knowledge management templates, archival processes, etc.)
· 3-5 years’ experience is required.
Industry experience with specific focus in the psychiatry therapeutic area.
Strong methodological, quantitative and analytical skills combined with a sound understanding of how to successfully apply HEOR principles to support the enterprise.
Strong project management skills with oversight experience in both internal and external projects are necessary
Publication/presentation track record with experience in medical/scientific writing, internal/external educational training on interpretation of HEOR data and resulting tools, third party payor support and KOL development.
Demonstrated understanding of the dynamics of the US and global health care systems and financing mechanisms.
Strong presentation and interpersonal skills with demonstrated ability in participating and leading cross-functional teams, excellent skills in leading without authority, and negotiating and managing through influence.
Strong track-record of being results-driven and showing accountability for achieving early wins and long-term success.
Master’s degree, PhD or Pharm D with an MPH strongly preferred.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.