Senior Submission Data Standards Lead


Sanofi
Bridgewater Township, New Jersey, United States


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.




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Senior Clinical Trial Biostatistician


Westat
Rockville, Maryland, United States


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.




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Statistical Analyst


Keyrus
Lasne, , Belgium


As Statistical Analyst, you :

  • Recognize and identify technical problems or data-related issues.
  • Identify and recommend solutions to problems.
  • Anticipate and address issues with customers or to a non-technical audience.
  • Are aware of project objectives and requirements with guidance.
  • Are able to deliver presentations with clarity.



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Study Data Manager


Keyrus
Lasne, , Belgium


As Study Data Manager, you collaborate closely with the Technical Data Manager.




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Principal Analyst, Data Standards


Biogen
Cambridge, Massachusetts, United States


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.




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Technical Data Manager


Keyrus
Lasne, , Belgium


As Technical Data Manager, you collaborate closely with the Study Data Manager. You are in charge of the technical part of the clinical studies. As so, you create and design a database for the clinical studies you are assigned to.




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