Job Description

JOB DESCRIPTION Location: Mumbai, Pune, Ahmedabad, Bangalore, Chennai, Hyderabad, Kochi, Gurgaon Mandate Skills: SDTM, ADAM, TLF on clinical trials phase 1-4` Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences. A minimum of 6+ 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) Understanding client\'s requirement and providing all the required statistical inputs on, SAP, Mock Shells, Tables, Listings, Figures, or any other statistical programming deliveries Good understanding of the statistical programming domain and related processes 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 Good verbal and written communication skills coupled with good organizational skills. Technical: 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 reviewing analysis data sets. Provide training and guidance to lower level and new staff. Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports) Compliance: 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.

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