Ref #: 30320

Employment type: Permanent - Full-Time

Location: Bangalore/Homebased

Posted: 01-Jul-2021

Description

Job Description:

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:

6+ 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.


Preferred only immediate joiners.