Clinical SAS programmer

1 week ago


Bengaluru, Karnataka, 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 7 years of experience in Statistical programming

(ADaM) 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

  • 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 , 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 program

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