Senior Associate, Senior Statistical Data Scientist

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.