Principal SDTM Programmer

1 week ago

India ICON Strategic Solutions Full time

Shift Timing: 2pm to 11pm IST


· Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Global Drug Development.

· Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.

· Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).

· Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT.

· Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.

· Provide and implement statistical programming solutions; ensure knowledge sharing.

· In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.

· Ensure 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 advanced 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 guidance.

· As assigned, act as subject matter expert (SME) or contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

Requirements:

· 8+ years’ work experience in a SDTM programming

· Experience in Creation of Specification and Annotation of CRF, Study data review guideline.

· Experience in creation of Define.xml for SDTM and Pinnacle 21 checks

· Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS).

· Good communications and negotiation skills, ability to work well with others globally.

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