Associate Director, Clinical Data Standards Lead
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ASSOCIATE DIRECTOR, CLINICAL DATA STANDARDS LEAD
Lead global SDTM data standardization activities and study level implementation in the Biostatistics and Programming (B&P) organization. Collaborate across the CSO (Clinical Sciences & Operations) platform to support the development, maintenance and governance of SDTM data standards and tools in B&P, in the framework of regulatory requirements, industry standards and CSO business strategy.
Lead activities in Programming Metadata Standards (PMS) team to support study level SDTM mapping as well as associated submission deliverables following our SDTM creation process.
Provide subject matter expertise in the application of clinical data standards to clinical study teams across all phases and therapeutic areas, as well as in the development of guidelines, templates and tools for SDTM data creation.
Champion continuous process improvements in the implementation of clinical data standards.
MAJOR DUTIES AND RESPONSIBILITIES:
*Lead activities to define and/or improve strategies for the implementation of the global SDTM data standards in B particularly with regard to SDTMIG assumptions and mapping strategies, statistical programming conventions, and CTD-CRT preparation (Define.xml development, CRF annotation, FDA submission expectations, use of Pinnacle 21, and SDTM compliance rule violation resolution).
*Reinforce the implementation of data standards within B&P through conducting trainings and workshops, and providing Q support the project teams, including their work with external partners and/or venders, to ensure submission readiness.
*Identify, author and review submission data standards related Guidelines and Work Instructions.
*Lead activities to develop, evaluate, and validate SAS macros and template programs related to the creation and validation of standard submission datasets.
*Support the identification, review, evaluation and implementation of new technologies related to clinical data standards.
*Lead or participate in data standards process improvement working groups.
*Participate in cross-entity end-to-end standards governance activities.
KNOWLEDGE AND SKILLS:
*In-depth knowledge in industry data standards and regulatory data submission requirements, with a focus on SDTM and electronic submission (eSub).
*Proven ability to work collaboratively on interdisciplinary teams; strong interpersonal skills that demonstrate initiative and motivation; proven ability to solve problems; excellent verbal and written communication skills in a global environment.
*Strong skills in project management and team leadership. Ability to effectively organize and manage multiple assignments, from project start-up through finalization.
*Demonstrated experience in the development and implementation of standardization methodology within at least one therapeutic area in pharmaceutical clinical development.
*Experience (direct or advisory) with the preparation of the full package (SDTM and ADaM) eSub deliverables (e.g., tabulation and analysis datasets, define.xml, annotated CRF, SDRG, ADRG, etc.) in compliance with current regulatory standards guidance and involvement in submission planning.
*Experience in participating in end-to-end global standardization initiatives.
*Experience in participating in industry-wide clinical data standards activities.
*SAS programming experience with focus on programming process optimization.
*Experience with a metadata repository tool a plus.
FORMAL EDUCATION AND EXPERIENCE:
*A candidate with a Bachelor of Science degree or equivalent in a relevant scientific discipline and 12+ years of experience preferably in processing clinical trial data in the pharmaceutical industry.
*A candidate with a Master of Science degree or equivalent in a relevant scientific discipline and 10+ years of experience preferably in processing clinical trial data in the pharmaceutical industry.
Primary Location: United States-New Jersey-Bridgewater
Base Salary - $110,000 to $150,000
Benefits - Full
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes
10+ to 15 years experience
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Location: New Jersey
Industry: Pharmaceutical / Biotech
Job Category: Research & Development
Visa Candidate Considered: Yes
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