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 Statistical Programming Lead (Standards) - Associate Director
Job Description
ROLE SUMMARY
• This role will provide oversight and mentoring of hands on statistical programming team supporting enterprise, study and asset level deliverables of standard statistical programming encompassing the following areas: CDISC SDTM, ADaM, and TLF generation
• 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
• In addition to management of the deliverables, the senior lead will also provide consultation to the asset/submission teams with respect to planning of programmed asset deliverables as well as standards strategy
• Ensures adherence to high quality programming standards in the production of clinical reports and submission documentation
ROLE RESPONSIBILTIES
• Will have people management responsibilities
• Will be a mentor to more junior colleagues
• Works with department leadership and project teams to establish strategy, timelines, and resourcing of statistical programming and analysis deliverables within their area
• 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 that software development lifecycle practices are followed and document as specified by our SOPs and best practices
• Ensures appropriate documentation is generated to support audit readiness in defense of our standard software development
• Works with statisticians, programming resources, and other colleagues as appropriate to ensure clear specifications for programmed deliverables are in place
• Excellent communication skill to ensure appropriate collaboration with statisticians, data managers, statistical programmers, clinical pharmacology leads, research data scientists and programming leads to ensure clear specifications for their programmed deliverables are in place
• Will be knowledgeable of software development practices as defined within Pfizer’s CDISC development framework
• Provides solutions to complex programming issues using problem solving skills and previous experience
• Will contribute to, and may lead department level initiatives. May also contribute to broader initiatives outside of the department
Candidate Profile
• Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field
• At least 8 years relevant CDISC statistical/clinical programming experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
• Statistical Programming and SAS hands-on experience
• Clinical trials data flow expertise from data collection through reporting
• Clinical trials expertise with a thorough understanding of the drug development process and data operations required for the reporting of clinical trial data (e.g. study reports, regulatory submissions, safety updates, etc.)
• Adept at solving problems using skills based on experience and extrapolation to new situations.
• Understanding of clinical data and relevant data standards
• Thorough knowledge of ICH guidelines and regulatory requirements
• Knowledge of vendor processes and best practices in outsourcing and oversight
• Experience working with a global programming team for necessary deliverables
• Demonstrated experience managing complex projects and developing successful partnerships within study and asset teams
• Strong written and oral communication skills, leadership, decision making, influencing, negotiation, and project management skills
• Proven ability to operate independently in ambiguous situations
• Proven ability to present technical information to a non-technical audience
• Sound knowledge and experience working across international boundaries and cultures.
• Ability to manage customer expectations, anticipate potential objections, and influence others
• Extensive knowledge of statistical methodology and its application to programming
• CDISC experience required
• Pfizer CDARS experience desirable
Additional Information:
Experience: 8 years
Location: Chennai
Education: Bachelor or Master
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Senior Statistical Programming Lead
Job ID: 1622238
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