Lead Standards team under DSO (Data Standards and Operations) to ensure the implementation and compliance of data standards within B&P(Biostatistics and Programming). Collaborates with global standards organization CIG (Clinical Information Governance) to manage all aspects of data standards queries and needs within B&P. Expands and mentors the standards team by developing expertise in CDISC and submission standards required by Health Agencies. Develops process to support centralized submission project delivery. Collaborates with the ART (Analysis and Reporting Tools) team to develop and maintain global reporting standard metadata end to end.
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.
Westat is seeking a Senior Clinical Trial Statistician to lead and support Phase 1- 4 clinical trials across a variety of therapeutic areas. The Sr. CT Statistician will collaborate with clients and sponsors, and manage, oversee, and expand capabilities of CT statistical staff.
As Statistical Analyst, you :
The Principal Analyst, Data Standards, drives the development, implementation and maintenance of Analytics and Data Sciences’ (ADS) clinical data standards capabilities. Successful candidate serves as an SME in defining best practices for Biogen’s implementation of standard models (e.g. CDISC CDASH, SDTM, Controlled Terminology, ADaM, Define.xml) to ensure drug submissions are compliant with industry regulations. He/she will apply an industry-facing focus to foster a consistent approach to employ clinical data standards and address governance requests. He/she leads or participates in cross-functional teams to coordinate data standardization efforts across ADS and other R&D functions. He/she will be instrumental in facilitating the rapid expansion of Therapeutic Area (TA) standards to enable end-to-end data flow optimization. Acting as a consultant, he/she supports and educates colleagues and clinical study teams across ADS. He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on ADS's behalf.