• 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 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.  

• 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 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.  

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 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 

 
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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