The Manager is primarily responsible to lead the governance and implementation of enterprise wide SDTM standards. He/She will collaborate across functions and provide comprehensive programming leadership and support to data management, statistical programming, biostatisticians and clinical teams to implement best practices/process maps to drive E2E data standards within Pfizer environment. This role will also be responsible for delivering study level SDTM artifacts across the portfolio. ROLE RESPONSIBILITIES:
- Develop and/or support implementation of enterprise level CDISC SDTM standards
- Responsible for quality and timely delivery of SDTM Annotated CRF's, Specifications, datasets along with Define.xml and Reviewer Guide) covering one or more Therapeutic Areas (Vaccines, Oncology , Dermatology, Inflammation, Pain, Neuroscience, etc).
- Will be knowledgeable of software development practices as defined within Pfizer's CDISC development framework.
- Ensures that software development lifecycle practices and essential procedures are followed, and document as specified by our SOPs and best practices.
- Will represent SDTM Programming standards in Study team meeting to provide subject matter expertise
- Collaborate with offshore development team and provide oversight of Vendor programming activities onshore/offshore to ensure adherence to Pfizer standards along with quality and timely deliverables.
- Work collaboratively with multiple stakeholders to manage priorities and resources across studies; understand and perform in accordance with regulatory standards.
- Proactively identifies problems and develops workaround tools that helps light speed study timelines
- Coordinate Database Release (DBR) activities, including unblinding
- Review, respond to, and implement changes based on regulatory feedback
- Master Degree with 3+ years of experience.
- Bachelor of Science degree in a relevant scientific discipline with 5+ experience in data standards, data management, and/or programming in a pharmaceutical setting.
- Knowledge of CDISC SDTM standards with hands on experience using Pinnacle21 to validate SDTM deliverables.
- Knowledge of clinical study design with understanding of CRF design.
- Knowledge of data management systems (i.e. OC/ RDC, Inform and LSH) and working knowledge of SAS/R/PYTHON programming.
- Working knowledge of Linux platform is preferred.
- Exposure to Machine Learning/AI driven SDTM process is a big plus
- Ability to leverage Experience to innovate and streamline workflows
- Demonstrated ability to work in a team environment with clinical team members.
- Excellent communication ability, as well as written, verbal, interpersonal and organizational skills.
- Strong knowledge of CDISC standards, regulatory submission requirements along with project management skills.
- Experience working with Functional Service providers is strongly preferred
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