- 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.
QUALIFICATIONS / SKILLS
- 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
- Bachelor or Master 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
Sr. Statistical Programmer-Sr. Mgr, Sr. Statistical Programming Lead - Director
Other Job Details:
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Eligible for Relocation Package: NO
- Eligible for Employee Referral Bonus: YES
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. 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.