Sandeep Aravind
Statistical Programming Associate Director @AstraZeneca
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WORK HISTORY
Statistical Programming Associate Director @AstraZeneca
Mississauga, ON, CA
Lead Statistical programming deliverables for regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions, commercialization and reimbursements. • Lead delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations • Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB) • Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
EDUCATION
Institute of Bioinformatics and Applied Biotechnology (IBAB)
Master's Degree, Bioinformatics and Applied Biotechnology
Sree Chitra Thirunal College of Engineering, Pappanamcode, Thiruvananthapuram
Bachelor of Technology (BTech), Biotechnology
ABOUT SANDEEP ARAVIND
Statistical Programmer with over 11 years of experience in all phases of a clinical trial, different therapeutic areas and domains, who thrives to be a better human by professionalism and humbleness; a book-lover; with a tinge of word artistry.Experienced in- Leading projects/products with multiple studies in various phases, resourcing and managing members within the team and vendors- Developing and maintaining SAS programs to create complete SDTM and ADaM datasets and TFLs, and performing validation of SDTM, ADaMs, and TFLs- Developing complex specifications for SDTMs and ADaM dataset and contributing to the development of internal and client standards- Reviewing SAP and TFL mock-shells, programming specifications, annotated CRFs from a programming perspective for studies, and advise on the development of complex TFL shells from a programming perspective- Mentoring and training new programmers in CDISC, client, and internal standards and ensuring adherence to department practices and processes- Experience in leading multiple studies and teams in parallel for full submission.
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