Senior Associate

The role is/includes

• 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 time zones
• 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 Pfizer 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 Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio. (Portfolio)
• Contributes to up to 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.

Qualifications/Skills

• 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 time zones 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

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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