ROLE SUMMARY
- A productive, hand on programmer who applies technical knowledge of CDISC and practical experience to deliver statistical programming deliverables leveraging CDISC constructs: SDTM, ADaM, and Control Terminology
- Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible
- Ensures adherence to high quality programming standards in their daily work
ROLE RESPONSIBILTIES
- Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC , ADaM, and TLF generation.
- Demonstrate experience working as part of a software development team and fundamental SDLC processes.
- Ensures excellence in the understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible.
- Ensures adherence to Pinnacle 21 CDISC validation checks and high-quality programming standards in their daily work.
- Exhibits routine and occasionally complex problem-solving skills, seeking direction when appropriate.
- Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.
- Will be knowledgeable of software development practices as defined within Pfizer's CDISC development framework.
- May contribute to department level initiatives.
QUALIFICATIONS
- Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field
- At least 5 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
- Statistical Programming and SAS hand-on experience
- Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
- Good understanding of ICH and regulatory guidelines
- Working knowledge of clinical data and relevant data standards
- 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 require.
- Pfizer CDARS experience desirable.
Work Location Assignment: Flexible
Work Location Assignment: Flexible
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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