Ref #: 26784

Employment type: Permanent - Full-Time

Location: Chennai, Bangalore and HomeBased

Posted: 08-Feb-2021


We are expanding our Statistical Programming Team and adding more.

Job Title: Senior Statistical Programmer (SDTM)
Job location: Chennai /Bangalore
Work type: Home based /Office based
Experience: 6+ years of relevant exp in SDTM domain and SAS Skills
Education Qualification: Any graduation
Salary: As per Industry standards with attractive benefits
Skill set: Experience in Creation of Specification and Annotation of CRF, Study data review guideline. 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.

Job Functions:

• 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 Novartis 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 deliverable 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.
• 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.