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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
277707BR
Senior Clinical ProgrammerJob Description
Your responsibilities: Your responsibilities include, but are not limited to: 1. Lead statistical programming activities as aCRFs, SDTM datasets and SDTM conversion/mapping, Define.xml, RGs for phase I to IV clinical studies or assigned project-level activities in Novartis Global Drug Development. 2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work. Make statistical programming recommendations at study level. Contribute to project level standards. 3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. with statistical programming team as member of the extended Clinical Trial Team (CTT). 4. Review eCRF, discuss data structures and provide inputs to the other stakeholders as member of the extended CTT 5. Comply with company, department and industry standards (e.g. CDISC) and processes, review and develop programming specifications as part of the analysis plans. 6. Provide input into data provisioning solutions and/or ensure their efficient implementation. 7. In consultation with the Statistician and programmer, responsible for development of SDTM programming specifications. 8. Ensure timely and quality development and validation of SDTM datasets and outputs regulatory submissions/interactions in the assigned drug development study/project according to specifications 9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC aCRFs, SDTM, RGs, eCTD, Define.xml), attend functional meetings and trainings.
Minimum requirements
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written). 1. Excellent SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables 2. Good experience in contributing to Specification documents for SDTM Mapping/Conversions. 3. Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs 4. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and clinical study practices, procedures and methodologies. 5. Good communications and negotiation skills, ability to work well with others globally. 6. Proven ability to produce timely and quality deliverables under guidance (at least 2 years). 7. Ideally 5-7 years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry. Division
Global Drug Development
Business Unit
GDO GDD
Country
India
Work Location
Hyderabad, AP
,Keyskills :
globaldrugdevelopment phasei lifesciences qualitycontrol datastructures computerscience drugdevelopment negotiationskills statisticalanalysis projectadministration tatementsofw ksow statisticalprog