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