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Pfizer SDTM Programming Standards Specialist in Remote, United States

ROLE SUMMARY:

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.

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

QUALIFICATIONS :

  • 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

#LI-PFE

#LI-Remote

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

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