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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Medical / Healthcare |
Functional Area | Web / Mobile TechnologiesSales / BD |
EmploymentType | Full-time |
252975BRSenior Clinical Programmer Job DescriptionPosition Purpose The Senior Clinical Programmer is responsible for all statistical programming aspects of assigned studies or project- level activities. The position is a key contributor with Data Provisioning team in ensuring that pharmaceutical drug- development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables.Major Accountabilities 1.Lead statistical programming activities as eCRFs, 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 requirementsBA/ 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.DivisionGlobal Drug Development Business UnitGDO GDD CountryIndia Work LocationHyderabad, AP Company/ Legal EntityNov Hltcr Shared Services IndFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular ,
Keyskills :
lifesciencesqualitycontroldatastructuressharedservicesclinicaltrialscomputersciencedrugdevelopmentstatisticalanalysistatementsofwksowglobaldrugdevelopmentphaseinegotiationskillsproj