Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Senior Research Scientist
ROLE SUMMARY
- A highly productive, independent programming lead ensuring excellence in the delivery of enterprise, standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation
- This role will provide oversight and mentoring of hands on statistical programming team
- Demonstrate experience working as part of a software development team and fundamental SDLC processes
- Ensures excellence in the understanding of CDISC IG requirements, NCI Control Terminology, and programming of analysis ready datasets, tables, listings, and figures for which they are responsible
- Ensures adherence to Pinnacle 21 CDISC validation checks and high quality programming standards in their daily work
- This role is the programming point of contact within the global standards development team
- Ensures adherence to high quality programming standards in the production of clinical reports
ROLE RESPONSIBILTIES
• Will deliver through combination of oversight of local development team support as well as through hands on programming
• Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables of our standards
• Accountable for the quality and timely delivery of enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation
• Ensures planning is in place for all programmed deliverables including consideration of special data types and downstream uses of data
• Works with statisticians, programming resources and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place
• Will be knowledgeable of software development practices as defined within Pfizer’s CDISC development framework
• Will contribute to department level initiatives.
• Proactive at communicating potential issues to upper management
• Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations
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Candidate Profile
• Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field
• At least 5 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
• Statistical Programming and SAS hands-on experience
• Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data
• Good understanding of ICH and Regulatory Guidelines
• Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations
• Thorough understanding of clinical data and relevant data standards
• Extensive knowledge of routine statistical methodology and its application to programming
• Knowledge of vendor processes
• Demonstrated experience in developing successful partnerships within study teams
• Strong written and oral communication skills, and project management skills
• Ability to present technical information to a non-technical audience
• Proven ability to operate independently
• Some exposure working across international boundaries and cultures
• Ability to manage customer expectations
• Ability to manage work of others in a remote and/or global setting
• CDISC experience require
• Pfizer CDARS experience desirable
Additional Information:
Experience: 5 years
Location: Chennai
Education: B.Sc, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Standards
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