Job Description
JOB SUMMARY
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.
Ensures excellence in the electronic submission data packages for which they are responsible.
Ensures adherence to high quality CDISC standards and FDA requirements in their daily work.
Confirms submitted electronic data are complaint with FDA regulations in submission review expectations.
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)Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.
Works with statisticians, programming leads, study programmers and standards programmers to ensure clear specifications and metadata for SDTM and ADaM are in place deliverables are in place.
Knowledgeable in CDISC conformance as well as TA standards pertinent to their project.
May aid in development of standards necessary for their study.
May contribute to department level initiatives.
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 - NO
Work Location Assignment:Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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