· A productive, hands-on programmer who applies technical knowledge and practical experience to deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role.
· 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.
JOB RESPONSIBILITIES
· Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may be programming
· Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables
· 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 in core safety standards as well as TA standards pertinent to their project, may aid in development of standards necessary for their study.
· May contribute to department level initiatives
QUALIFICATIONS / SKILLS
· Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
· At least 6-8 years relevant 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 desirable
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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