Principal Statistical Programmer

1 week ago

Chennai, India Pfizer Full time

At least 5+ 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.
- 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.
- Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.

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.

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