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Statistical Programming Lead (Sr. Research Scientist)

Pfizer


Location:
Austin, TX 78728
Date:
01/26/2018
2018-01-262018-03-02
Pfizer
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Job Details

Job Description Summary:







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



This role is the programming point of contact at the study level, and will support at the asset/submission level.



Ensures adherence to high quality programming standards in the production of clinical reports.







Job Description:







Will deliver through combination of oversight of vendors/offshore support as well as through hands on programming



Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables for their study(ies).



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 contribute to under the leadership of the asset lead. Ensures appropriate documentation across the lifespan of the study for all programming deliverables and verifies proper Trial Master File filings when appropriate.



Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data



Works with statisticians, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place.



Will be knowledgeable in core safety standards as well as Therapeutic Area standards pertinent to their project, may aid in development of standards necessary for their study



Will contribute to department level initiatives.



Proactive at communicating potential issues to upper management



Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations







Qualifications:



Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.



At least 5 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.



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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