QUALIFICATIONS / SKILLS
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- Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
- At least (8-15) years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
- Statistical Programming and SAS hands-on experience
- Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.
- Good understanding of ICH and Regulatory Guidelines
- Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.
- Thorough understanding of clinical data and relevant data standards
- Extensive knowledge of routine statistical methodology and its application to programming
- Knowledge of vendor processes
- Demonstrated experience in developing successful partnerships within study teams
- Strong written and oral communication skills, and project management skills
- Ability to present technical information to a non-technical audience
- Proven ability to operate independently.
- Some exposure working across international boundaries and cultures.
- Ability to manage customer expectations.
- Ability to manage work of others in a remote and/or global setting
CDISC experience highly desirable
Responsibilities:
A highly productive, independent programming lead ensuring excellence in the delivery of analysis ready datasets, tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes
The programming point of contact at the study level, and will support at the asset/submission level(TA and Study) , supporting end to end deliverables in the study/project/portfolio/standards teamhigh complex statistical programming deliverables to support assets and study teams
Guide, mentor, monitor programmers within the team and collaborate with Senior SDSL’s on timelines, resource management and deliverables with quality.
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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