Manager, Statistical Programming

Responsibilities Review analysis plans for appropriate methodologies Review clinical data as SDTM datasets Develop analysis databases (ADaM) Program study analyses and review study results Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation Communicate project requirements for data cleanup and data capture to ensure key variables are suitable for analysis Assist in developing and implementing departmental standards, applications, processes, and training Identify consultants/select service providers and oversee statistical and programming deliverables by CROs or service providers Requirements Master’s degree in Biostatistics/Statistics 4 years of relevant programming experience in pharmaceutical or biotechnology drug development Proficiency with SAS; familiar with R Studio Excellent verbal and written communication skills; effective cross-functional collaboration and influenceUnderstanding and experience across the clinical development life cycle through regulatory submission and post-approval activities Experience interacting with and overseeing programming services of CRO vendors Knowledge of cross-functional department functions/roles within a drug development company Preferred Understanding of regulatory guidelines for CDISC dataset submission; experience developing SDTM and ADaM specifications Compensation California pay range: $145,000 USD - $160,000 USD Eligibility Candidates must have current, valid authorization to work in the country where this role is located. #J-18808-Ljbffr Scorpion Therapeutics