Job title: Clinical Sas Programming/pan India
Job description: Understanding clients requirement and providing all the required statistical inputs on, SAP, Mock Shells, Tables, Listings, Figures or any other statistical programming deliveries Assists with developing, monitoring, and enforcing productivity and q
Understanding clients requirement and providing all the required statistical inputs on, SAP, Mock Shells, Tables, Listings, Figures or any other statistical programming deliveries Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentations Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity Provide training and guidance to lower level and new staff What you need A Graduate/Post-Graduate degree in Statistics/Mathematics/Computer Science/Life Sciences A minimum of 4 years of total experience with a at least 2 years of experience in Statistical programming and/or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or Pharmaceutical or Biotechnology company Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents (e.g. USFDA and EMEA) Good understanding of the statistical programming domain and related processes Good verbal and written communication skills coupled with good organizational skills Strong Analytical and programming Skills using statistical software SAS or equivalent with understanding of development and/or execution of SAS macros Knowledge of R will be an added advantage Should have worked on generating and validating tables, listings and figures Should have worked on Derived datasets/Analysis Datasets/ADaM/SDTM More complex review (programs with high risk) Programming and review of outputs for DSUR, PSUR, publications Exposure on Exploratory analyses is an added advantage Programming and review of analysis data sets. Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports) Adherence to SOPs and GPP Quality and adherence to timelines. Self – motivation and self – learning Achievement orientation & Relationship building ability Inclination towards being process driven
Location: Secunderabad, Telangana
Job date: Sun, 20 Feb 2022 23:27:27 GMT
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