Sr. Associate Statistical Programmer (SDTM Standards)

Collegeville, Pennsylvania; Peapack, New Jersey
June 10 2021
Position Type
Full Time
Organization Type

The Senior Statistical Programmer (SDTM Standards) - Sr. Associate has an understanding of CDISC standards data collection process and analysis reporting, is responsible for liaising with the data management, statistical programming, biostatisticians and clinical teams. The SDTM programmer will be actively involved in providing support for implementation of CDISC standards within organization and implementation of process maps to drive E2E data standards within Pfizer environment.

  • Develop and/or support implementation of enterprise level CDISC SDTM standards
  • Res ponsible for quality and timely delivery of SDTM Annotated CRF's, Specifications, datasets (along with Define.xml and cSDRG) covering all major Therapeutic areas (Vaccines, Oncology, Dermatology, Inflammation, Pain, Neuroscience, etc).
  • Will be knowledgeable of software development practices as defined within Pfizer's CDISC development framework.
  • Ensures that software development lifecycle practices and essential procedures are followed, and document as specified by our SOPs and best practices.
  • Will re present SDTM Programming standards in Study team meeting to provide subject matter expertise.
  • Collaborate with offshore development team and provide oversight of Vendor programming activities onshore/offshore to ensure adherence to Pfizer standards along with quality and timely deliverables.

  • Bachelor of Science degree in a relevant scientific discipline.
  • 2-3 years of experience in data standards, data management, and/or programming in a pharmaceutical setting.
  • Must have pharmaceutical industry professional experience.
  • Kno wledge of CDISC SDTM standards with hands on experience using Pinnacle21 to validate SDTM deliverables.
  • Kno wledge of clinical study design with understanding of CRF design.
  • Knowledge of data management systems (i.e. OC/ RDC, Inform and LSH) and working knowledge of SAS/PYTHON programming.
  • Working knowledge of Linux platform is preferred.
  • Exposure to Machine Learning/AI driven SDTM process is a big plus
  • Ability to leverage Experience to innovate and streamline workflows

Last Date to Apply for Job: May 25th, 2021

Eligible for Relocation Package: NO

Eligible for Employee Referral Bonus: YES


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.


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