Job Description

Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences. A minimum of 7 years of total experience with at least 5 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\xe2\x80\x99s 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 review of 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

Employee Status : Full Time Employee Shift : Day Job Travel : No Job Posting : Dec 28 2022
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