Senior Manager - Medical Affairs*

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world. Job Title: Real World Evidence (RWE) Analyst Location: Santa Monica, CA or remote Duration: 6 Months contract Payrate: $75/hr - $85/hr Job Description:The RWE Analyst will contribute to the Kite Real-World Evidence/Health Economic Outcomes Research (RWE/HEOR) Team as part of an effort to contribute to the strategies of the broader Kite Evidence Generation Team, which will include the conduct of timely, relevant, and rigorous analysis of real-world data (RWD) to address critical research questions and contribute to cross-functional initiatives.The RWE Analyst will be responsible for developing, reviewing, and providing feedback on study documents, such as protocols and statistical analysis plans, and executing planned data analyses using administrative claims, electronic health record (EHR), and observational registry databases.The RWE Analyst will work closely with project teams to manage timelines and workflows, and to communicate results and updates to internal cross-functional stakeholders, including people from Kite Biometrics, Clinical Operations, and Safety.The RWE Analyst will have access to real-world databases licensed across and act as stewards of best research practices, standards, and methodologies underlying the use of RWE. Key Responsibilities:Support development of and provide critical appraisal of study protocols for research projects using RWD (e.g., medical claims, EHR, and observational registry databases)Lead or support development of statistical analysis plans in collaboration with internal stakeholders (e.g., Kite Biometrics and programming team members)Conduct data reviews for primary/secondary data collected to ensure quality and reliabilityCommunicate study results with a broader internal cross-functional audienceAdapt performance metrics and dashboards for RWE projectsSupport preparation of reports and/or publication materials (e.g., abstracts, manuscripts)Support cross-functional initiatives to develop and refine internal procedures, workflows, and best practices Basic QualificationsMaster's degree in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution and 4+ years of experience working with a broad range of RWD, in academia, at a contract research organization, or in the biopharmaceutical industryORBachelor's degree in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution and 6+ years of experience working with a broad range of RWD, in academia, at a contract research organization, or in the biopharmaceutical industry Preferred Qualifications:Master's degree or Doctoral level training in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution4+ years of oncology research experience highly preferredIn-depth knowledge of claims-based RWD (e.g., HealthVerity, Optum) and prior experience of using claims-based RWD in oncology researchExperience working with EHRs (e.g., IQVIA, Flatiron) and registry databasesPrior experience of using RWD for RWE in regulatory applications, post-marketing studies, and pharmacovigilanceExperience with external control arm (ECA) methodologiesIn-depth understanding of the principles of epidemiologic research methods and statistical concepts in support of the analyses and demonstrated proficiency in statistical analysis programming languages commonly used in life sciences (e.g., SAS, R)Experience in biopharmaceutical industryExcellent verbal, written and presentation skills, including the ability to effectively communicate statistical methodology and analysis resultsAbility to work independently and collaboratively in a constantly changing, diverse, and matrix environment If you have any questions, feel free to call me on (415) 322-5419 or send an email on Akarsh Yathiraj