Senior Associate, Senior eSub ProgrammerUnited States - New York - Pearl RiverUnited States - Connecticut - GrotonUnited States - Pennsylvania - CollegevilleWe're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
A productive, hands-on programmer who applies technical knowledge and practical experience to deliver electronic submission data packages to support regulatory submissions and study teams with limited supervision, early in role and independently later in role.
JOB RESPONSIBILITIES Develop or facilitate the quality and timely delivery of data packages for tabulation (SDTM), analysis (ADaM) and site selection (BIMO) needed for FDA submissions.Ensure appropriate documentation and QC all components of electronic submission (eSub) data packages, including XPT files, annotated CRF(aCRF), define.xmls and Data Reviewer's Guides (DRG).Works with statisticians, programming leads, study programmers and standards programmers to ensure clear specifications and metadata for SDTM and ADaM are in place.Knowledgeable in CDISC conformance as well as TA standards pertinent to their project.Collaborate with study programmers and programming leads to ensure technical accuracy in aCRFs, defines and DRGs.Validate SDTM and ADaM data and define.xmls in Pinnacle 21 Enterprise.QUALIFICATIONS / SKILLS Bachelor or master's degree in Statistics, Biological Sciences, IT, or related field.At least 3 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.Statistical Programming, eSub data packages and SAS hands-on experience is a MUST.Clinical trials expertise with an understanding of data operations required for submission of clinical trial data to Health Authorities.Good understanding of ICH and regulatory guidelines.Working knowledge of clinical data and CDISC data standards required.Strong written and oral communication skills, and project management skills.Proven ability to operate with limited oversight.Knowledge of at least 1 Therapeutic Area.Proven ability to manage delivery under tight timelines.CDISC experience required.Experienced with the Pinnacle 21 Enterprise validation required.Other Job Details: Last Date to Apply: November 18, 2024.Geography includes: USA - NY, NJ, CT, PA.Eligible for Relocation Package - NOWork Location Assignment: HybridThe annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary.
Relocation assistance may be available based on business needs and/or eligibility.
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