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    Team Leader - Mumbai, India - Cognizant Technology Solutions

    Cognizant Technology Solutions
    Cognizant Technology Solutions Mumbai, India

    1 month ago

    Default job background
    OTHER
    Description

    Team Leader

    JOB DESCRIPTION – SAS Programmer

    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 , 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.



    SNo



    Primary Skill



    Proficiency Level *



    Rqrd./Dsrd.



    1



    SAS Programming



    PL3



    Required


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