Senior Associate, Senior eSub Programmer

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

The 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. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Medical

#LI-PFE