Clinical SAS Programmer

3 weeks ago

Chennai, India 2coms Full time
Job Description

This is a remote position.

Location: PAN India (WFH)


JOB Description:

  • Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
  • At least 4 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 the understanding of the 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 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



Requirements
Clinical SAS, SDTM,ADTM,TLF,TMF

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