Job type Full-time
Summary of Responsibilities
Work to create/maintain library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the data standards targets. Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other R&D functions that process data (e.g. Non-clinical).Work to create/maintain the package of specifications of data requirements to be communicated to CROs and other data processing vendors performing clinical development work for Data Science. Act as the sole communicator to internal/external resources of data-related requirements. Act as liaison between Data Management, Clinical Data Programming, Statistical Programming, and Biostatistics to promote data standardization within Data Science that encompasses raw data, SDTM, and ADaM datasets. Act as liaison between Data Science and other functions such as Medical Writing, Clinical Research, Regulatory, etc. to ensure that clinical trial documents incorporate required standardized terminology to facilitate data acquisition and integration, with minimal reformatting and translation. Act as liaison between COMPANY and CDISC or other SDOs to communicate needs regarding new terminologies, reviews of drafts of new/updated standards documents, etc. Work with Regulatory Operations and Project Teams to communicate COMPANY’s data submission plans as part of regulatory filings. Work with Clinical Data Programming and Statistical Programming to continue the refinement of validation checking on all data deliverables. Leverage data standards wherever possible to increase efficiency in data processing both internally and at external service providers, regardless of provider.
•Provide support across Data Science functional areas to promote and enforce the use of company data standards. Maintain metadata libraries of company standards, as adapted from industry standards, to be used by various functional groups performing data processing. Establish standards governance framework.
•Review and assess the impact of newly released and updated data standards from SDOs and incorporate into COMPANY’s business practices, as applicable.
•Review and assess the impact of newly released and updated regulatory agency prescriptions regarding data standards and incorporate into COMPANY’s business practices, as applicable.
•Promote the development of processes, tools and utilities within Data Science that leverage standardized data in order to increase efficiency of data processing, from data acquisition through data analysis, reporting and submission.
•Prepare internal SOPs and SWIs related to the use of data standards
•Communicate COMPANY’s data requirements to external vendors. Interact with external vendor personnel regarding standardized data transfer specifications, as necessary.
•Interact with SDOs and/or regulatory agencies regarding COMPANY’s data submission requirements and plans.
•Assist with NDA preparation planning as regards the use of CDISC standards.
Minimum education requirements Bachelors
Experience required 7 – 10 Years
Knowledge & skills (general and technical)
•Experience creating CDISC SDTM and ADaM datasets and strong familiarity with CDISC Controlled Terminology is highly desirable.
•Experience with creation and review of CDISC-formatted electronic submission deliverables is desirable.
•Knowledge of CDISC SEND model is desirable.
•Experience working with SDOs or data submission preparers is desirable
•Strong experience with databases or other controlled metadata repositories.
•Strong experience with document maintenance, version control, implementing upgrades, etc.
•Strong communication skills, both oral and written.
•Strong organizational and time management skills and the ability to handle multiple assignments effectively and deal with ad hoc requests.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required) •Bachelor degree and 7+ years in the pharmaceutical industry, preferably in a data science or regulatory capacity.
•Experience with implementing/working with metadata repositories/management systems is highly desirable CDISC training/experience is a requirement.
•Demonstrated knowledge of current and planned FDA data submissions requirement.
•Demonstrated experience in standards governance capacity.
•Working familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC, PhUSE).
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of THE COMPANY are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.