Senior Manager, Statistical Programming

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products.

Independent project programmer for major complex drug project, and/or project/technical leader on non-clinical project requiring matrix supervision and coordination of personnel. Ability to offer consulting, training and support to users on applications/template macros (developed by internal staff) and CDISC (SDTM and ADaM) standards. Independent programming representative on major PCH initiatives.

*Act as independent project programmer for assigned projects, take a programming leadership role on the programming project team.

*Manage complex projects.

*Oversee programming style, quality of programming contributions and compliance with internal and external quality standards, processes and timelines.

*Develop and implement project / study standards and specifications, including using CDISC SDTM and ADaM standards, for assigned projects in compliance with internal and regulatory guidelines.

*Plan resources for key sub-areas within programming group (e.g., a complex project).

*Ensure that the study protocol,CRF, annotated CRF and SAP are consistent and data points collected, analyses described in such a way that they can comply with company programming standards.

*Program analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE according to specifications and Pfizer SOPs/standards.

*Ensure appropriate documentations of programs, conventions, revisions of programming output following internal and external standards/SOPs

*Participate in the selection of CROs and supervise programming activities for CROs.

*Keep up-to date with state of the art programming techniques.

*Induct, supervise (matrix) and train programmers on programming skills, trial and project level activities, and internal processes, including programming team in China.

*Efficiently and effectively perform independent validation on other programmer's deliverables, and CDISC standards compliance.

• Education: BS/MS in statistics, mathematics, or computer science related area. MS in statistics is preferred.
• Experience: (12) Tweleve+ years SAS programming experience in pharmaceutical industry, Biotechnology Company, and a good understanding of statistical methodology. (2) Two+ years project management/team lead in programming. Experience in CDISC. Involvement in CDISC implementation is a plus.