Novartis
Location
Secunderabad | India
Job description
Lead and coordinate activities of all statistical programmers as Trial Programmer for phase I to IV clinical studies or assigned project-level activities. Make statistical programming recommendations at study level.
• Build and maintain effective working relationship with cross-functional teams, discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team (CTT).
• Review eCRF, discuss data structures and participate in data review activities in accordance with the company, department and industry standards (e.g. CDISC). Processes, review and develop programming specifications as part of the analysis plans.
• Provide input into statistical programming solutions and/or ensure their efficient implementation. Responsible for development of programming specifications of analysis datasets and pooled datasets.
• Ensuring timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
• Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidelines. Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives.
Role Requirements :
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field with Ideally 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry.
• Good knowledge of industry standards including CDISC data structures as well as understanding of the development and use of standard programs.
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).
• Good communications and negotiation skills, ability to work well with others globally, standardization and other non-clinical initiatives.
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