Description:Statistical Programming Liaise with various internal and external groups (Clinical, Statistics, Data Management, Regulatory, Pharmacovigilance, and external vendors including CROs and regulatory bodies) for the implementation of programming needed for internal data exploration, and regulatory submissions.
Ensure high quality, compliant programming to produce the SDTM/ADaM datasets, tables, and statistical analyses needed for regulatory compliant output with consistency across the clinical programs and on-time delivery.
Oversee programming and validation of eCTD submission deliverables including annotated CRFs, define files, reviewer's guides, and computational methods documentation.
Ensuring QC of vendor programming deliverables; Ensuring the review of DTA/DTS specifications for external data transfers.
Responsible for the design, development, and implementation of technical solutions for integrating, analyzing and reporting clinical data.
Review and monitor project timelines, adjust, if necessary, to ensure project can meet both planned and unplanned needs in a timely manner.
Supervision and management of statistical programming staff, contractors, and vendors; provide staff with reliable guidance to succeed and grow.
Responsibility for programming SOPs and Guidelines development and revision.
Update skills continually with respect to evolving industry standards, statistical concepts, regulatory, expertise, and therapeutic area knowledge.
Leads oversight of data management for outsourced clinical trials including project management, vendor management, coordination of internal reviews and data cleaning process, and approval of deliverables
Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy.
Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check programs/specifications, data entry and query status tracking, and database closure.
Develops and maintains data management SOPs and policies as required to maintain overall quality and consistency of Data Management
Oversees database design and production, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs.
Qualifications:Data Analytic experience
SAS / STATS Programming experience
Experience / Ability to manage vendors
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