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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead project management for clinical database design, build, and maintenance. Ensure data integrity, compliance with SOPs and Pfizer standards, perform impact analyses, manage risks, and collaborate with cross-functional teams to deliver high-quality clinical data capture solutions.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Owns availability, performance, and continuity for a portfolio of R&D applications. Manages vendors, SLAs/OLAs, incidents, change and lifecycle planning, DR testing, monitoring and performance analysis. Partners with shared services, client partners, projects and business to ensure production readiness, automation opportunities (including GenAI), and compliance in a regulated environment.
Top Skills:
GenaiItilSfia
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead administration and continuous improvement of Veeva eQMS for Regulatory Quality Assurance. Own access management, release coordination, reporting, and user documentation. Provide Vault configuration expertise, triage enhancement requests, represent Digital Systems in cross-functional programs, support data extracts and reporting, and drive AI-enabled process improvements and platform transformation within a GxP-regulated pharmaceutical environment.
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Ai-Enabled ToolsDataikuDssEqmsMicrosoft Power AutomatePower BISnowflakeSpotfireSQLVeevaVeeva Vault Eqms
- An Individual Contributor role
- Productive h ands 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/ s tudy deliverables and also to assist S DS L's with the team assignments.
- Review/ Develop/Validate /Review datasets, TFL as per CDISC aligned Standards or Data Standards for Study/Project/Portfoli o. (Portfolio)
- Contributes to upto 8 0% 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, b iological s ciences, 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.
Medical
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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