Senior Associate, Principal Statistical Data Scientist

2 weeks ago


Chennai Tamil Nadu, India Pfizer Full time

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 Work Location Assignment Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates Medical


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