One of our clients is looking for Clinical SAS programmer.

This is a remote position.

Location: PAN India (WFH)

• 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

• 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 (Define.xml, SDRG, ADRG, P21 reports)

• 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