Biostatistics Director

Das ist der Job

ph3About the Role: /h3 pDevelops strategic and operating plans for area of responsibility.

Darum lohnt es sich

OR /li liPhD in statistics, biostatistics or related discipline AND 7+ years of similar experience as noted above /li liInternal thought leader and recognized expert in a discipline /li liRequires broad expertise in theories and techniques within an area of responsibility /li liAbility to drive strategic direction into tactical plans /li liStrong mentoring skills and leadership abilities may mentor/coach lower levels and/or leads indirect teams /li liExperience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements /li liKnowledge of global regulatory and HTA requirements for RWE /li liDemonstrated ability in evaluation and development of RWE from conceptualization through application /li liExperience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development /li liExtensive working experience with stakeholders such as medical affairs and health economics /li liHands-on experience with prospective and retrospective observational studies /li liExperience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries /li liExcellent organizational skills and proven ability to effectively lead multiple projects to successful completion /li liHigh level of competency using standard statistical software such as SAS or R /li liAbility to effectively interpret and communicate research results to internal and external audiences /li /ul pNeurocrine Biosciences is an EEO/Disability/Vets employer. /p /p Serves as overall statistical lead and point of contact representing Biometrics in partnership 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. /p h3Your Contributions: /h3 ul liServes as statistical lead and represents Biometrics on health outcomes and epidemiology studies /li liProvides strategic and tactical support for cross-functional RWE development for regulators, payers and clinicians /li liServes as subject matter expert for RWE/HEOR research design, methodologies, data sources, analytic techniques, and reporting /li liLeverages administrative claims, electronic medical records, or other real-world data and recommends optimal study designs /li liSelects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives /li liDevelops high quality study protocols, statistical analysis plans, study reports, and other study documents /li liEnsures quality and consistency of analytics deliverablesIdentifies innovation opportunities for the use of RWD /li liEstablishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWE /li liCollaborates with and manages vendors to ensure project timelines and goals are met /li liPerforms other duties as assigned /li /ul h3Requirements: /h3 ul liMaster’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.