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.
