
Senior Manager, Statistical Programming
Posted Jul 30

Posted Jul 30
This is a fully remote position, open to applicants in New Jersey.
β’ Offer programming expertise to clinical project teams to facilitate the development, regulatory approval, and market acceptance of company products.
β’ Conceptualize, create, and execute technical solutions for the integration, analysis, and reporting of clinical data.
β’ Cultivate collaborative relationships within the Global Biometrics and Data Sciences organization, external vendors, and members of interdisciplinary development teams.
β’ Implement programming strategies, standards, specifications, and programmed analyses to ensure compliance with regulatory requirements, standard operating procedures, and operational practices.
β’ Create, validate, troubleshoot, and maintain programs and utilities in accordance with established specifications and standards.
β’ Assist with electronic submissions through preparation and review processes.
β’ Create programming specifications and review essential planning documents such as statistical analysis plans, data presentation plans, and data review plans to align with project goals.
β’ Ensure that programming assumptions and requirements are clear and comprehensive.
β’ Evaluate the robustness of documents and their impact on programming activities.
β’ The employer will accept a Masterβs degree or its foreign equivalent in Statistics, Business and Information Systems, Industrial Management, Computer Science, or a related field, along with three (3) years of relevant work experience as a Statistician or in a similar role.
β’ Must possess three (3) years of experience in the following areas (which may be acquired concurrently): β’ Utilizing R for generating derived analysis datasets and TFLs; β’ Implementing clinical data structures according to Clinical Data Interchange Standards Consortium standards and relational databases; β’ Employing SAS, XML, and Pinnacle 21 to create analysis datasets and TFLs; β’ Processing upstream data that includes various data forms, workflows, eDC, and SDTM; and β’ Delivering downstream outputs such as ADaM, TFLs, and components for e-submissions.
β’ Health Coverage: Medical, pharmacy, dental, and vision care.
β’ Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
β’ Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
β’ Paid Time Off for US Exempt Employees: flexible time off (unlimited, pending manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees); for Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours of annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
Medtronic
Sunbelt Rentals, Inc.
The Cigna Group
U.S. Bank
Get handpicked remote jobs straight to your inbox weekly.