The Senior Statistical Data Scientist is responsible for delivering statistical programming outputs including datasets and reports, ensuring high quality and adherence to standards. They collaborate with statisticians, manage project deliverables, and apply knowledge of CDISC guidelines and clinical trial data through software development practices.
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.
Medical
#LI-PFE
Top Skills
Adam
Cdisc
SAS
Sdtm
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