Employment Information
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An Individual Contributor role
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Productive hands on programming, supporting deliverables in the study/project/portfolio/standards team, of medium -- high complex statistical programming deliverables to support assets and study teams
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Performs tasks independently with mentorship or advise from Programming Leads within the organization
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Acts as co-lead/lead on selected projects/initiatives/activities and also study deliverables as needed.
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Guide, mentor, monitor programmers within the team and collaborate with SDSL's on timelines, resource management and deliverables with quality.
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Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones
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Ensures adherence to high quality programming standards in their daily work
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Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance.
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Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.
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Active self-learning and delivering on solutions in the space of statistical programming and data standards
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Contribute to SDSA initiatives globally and locally.
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Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team
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Accountable for their assigned work supporting the standards/study deliverables and also to assist SDSL's with the team assignments.
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Review/Develop/Validate/Review datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio. (Portfolio)
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Contributes to upto 80% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python and 20% to self learning, development and growth.
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Explore the existing code base and execute/perform runs as required, also develop/modify as per the needs and specifications suggested to the standards team as appropriate -- (Standards Programming)
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Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables across Standards, Programming and Submissions.
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Understand/Implement standard/study/project/portfolio requirements and specification and work with global stakeholders in ensuring completion of project/study/deliverable goals and milestones
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Knowledgeable in core safety standards as well as TA standards pertinent to their project and lead development of standards necessary for their study
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Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.
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Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning
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Support in accomplishing department and organization mission by completing assigned tasks
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Acts as mentor to junior team members
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Advances job knowledge to next level by participating/contributing in/to opportunities both globally and locally.
QUALIFICATIONS / SKILLS
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Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field.
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At least 5 - 6 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
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Understanding of clinical data and drug development process, CDISC standards required
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Statistical Programming and SAS hand-on experience
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Clinical trials expertise with an understanding of data operations required for the reporting of clinical
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Good understanding of ICH and regulatory guidelines
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Working knowledge of clinical data and relevant data standards
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Is able to work with stakeholders across timezones under tight timelines
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Strong written and oral communication skills, and time and project management skills
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Strong competencies and interests for innovation and problem solving
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Proven ability to operate with limited oversight
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Knowledge of at least 1 Therapeutic Area
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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