Responsible for all programming aspects (analysis datasets, pooled datasets, listings and tables) of individual clinical trials as needed. Supervise CROs as required and ensure timely deliverables with highest quality. 1. Lead the programming activities for a trial or publication activities. 2. Maintain efficient interfaces with internal and external customers with support of CDS management, Program Programmer/Statistician and CPOs as needed. 3. Develop resource plans as required with support of the Program Programmer. 4. Develop and comply with project / study standards and specifications following internal guidelines. 5. Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities. 6. Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for clinical trials with high quality and within milestones. 7. In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings 8. As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, pooled datasets, listings, summaries, figures and tables for clinical trials. 9. Support quality control and quality audit of deliverables. 10. Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation 11. Participate in the selection of CROs and supervise the trial activities of the CROs as needed. 12. Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Programming Quality Audit Clinical Trials Quality Control Data Structures Project Analysis Statistical Programmer SR Database Design SAS
Desired Candidate Profile:
UG: B.Sc – Computers, Statistics, B.Tech/B.E. – Computers, BCA – Computers
PG:Any Postgraduate – Any Specialization, Post Graduation Not Required
Doctorate:Doctorate Not Required
University or college degree in life science, computer science, statistics or equivalent relevant degree. Fluent English (oral and written). 1. Intermediate knowledge of / experience with SAS software. 2. Working knowledge of database design/structures. 3. Good understanding of global clinical trial practices, procedures, methodologies. 4. Good understanding of regulatory requirements relevant to SR (e.g. GCP, ICH). 5. Intermediate knowledge of office tools. 6. 3 – 5 years experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry
Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
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