Pfizer SDTM Programming Standards Specialist in Remote, United States
The Statistical Programmer 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.
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
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.