Clinical SAS programmer
1 week ago
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
- 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
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