Biostatistics Director, Osavampator
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
Develops strategic and operating plans for the Biometrics area. Serves as the overall statistical lead and primary contact for Biometrics, partnering with Medical Affairs, Health Economics and Outcomes Research (HEOR), and other departments to support the development and execution of real world evidence (RWE) strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings, and dissemination/publications. Ensures scientific rigor and serves as the analytical methodology expert for RWE study designs and data analyses across various data types and applications. Responsibilities
Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies Provides strategic and tactical support for cross-functional RWE development for regulators, payers and clinicians Serves as subject matter expert for RWE/HEOR research design, methodologies, data sources, analytic techniques, and reporting Leverages administrative claims, electronic medical records, or other real-world data and recommends optimal study designs Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives Develops high quality study protocols, statistical analysis plans, study reports, and other study documents Ensures quality and consistency of analytics deliverables Identifies innovation opportunities for the use of RWD Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWE Collaborates with and manages vendors to ensure project timelines and goals are met Performs other duties as assigned Qualifications
Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience leading the design and conduct of observational research in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements, and the development of drug development strategies in the pharmaceutical industry setting including innovative study designs and advanced statistical methods. Extensive previous leadership experience required. OR PhD in statistics, biostatistics or related discipline AND 7+ years of similar experience as noted above Internal thought leader and recognized expert in a discipline Requires broad expertise in theories and techniques within a area of responsibility Ability to drive strategic direction into tactical plans Strong mentoring skills and leadership abilities may mentor/coach lower levels and/or leads indirect teams Experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements Knowledge of global regulatory and HTA requirements for RWE Demonstrated ability in evaluation and development of RWE from conceptualization through application Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development Extensive working experience with stakeholders such as medical affairs and health economics Hands-on experience with prospective and retrospective observational studies Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion High level of competency using standard statistical software such as SAS or R Ability to effectively interpret and communicate research results to internal and external audiences
#J-18808-Ljbffr
Develops strategic and operating plans for the Biometrics area. Serves as the overall statistical lead and primary contact for Biometrics, partnering with Medical Affairs, Health Economics and Outcomes Research (HEOR), and other departments to support the development and execution of real world evidence (RWE) strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings, and dissemination/publications. Ensures scientific rigor and serves as the analytical methodology expert for RWE study designs and data analyses across various data types and applications. Responsibilities
Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies Provides strategic and tactical support for cross-functional RWE development for regulators, payers and clinicians Serves as subject matter expert for RWE/HEOR research design, methodologies, data sources, analytic techniques, and reporting Leverages administrative claims, electronic medical records, or other real-world data and recommends optimal study designs Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives Develops high quality study protocols, statistical analysis plans, study reports, and other study documents Ensures quality and consistency of analytics deliverables Identifies innovation opportunities for the use of RWD Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWE Collaborates with and manages vendors to ensure project timelines and goals are met Performs other duties as assigned Qualifications
Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience leading the design and conduct of observational research in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements, and the development of drug development strategies in the pharmaceutical industry setting including innovative study designs and advanced statistical methods. Extensive previous leadership experience required. OR PhD in statistics, biostatistics or related discipline AND 7+ years of similar experience as noted above Internal thought leader and recognized expert in a discipline Requires broad expertise in theories and techniques within a area of responsibility Ability to drive strategic direction into tactical plans Strong mentoring skills and leadership abilities may mentor/coach lower levels and/or leads indirect teams Experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements Knowledge of global regulatory and HTA requirements for RWE Demonstrated ability in evaluation and development of RWE from conceptualization through application Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development Extensive working experience with stakeholders such as medical affairs and health economics Hands-on experience with prospective and retrospective observational studies Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion High level of competency using standard statistical software such as SAS or R Ability to effectively interpret and communicate research results to internal and external audiences
#J-18808-Ljbffr