pharmalex_job_career



We are growing, grow with us!

Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

 

Specialist/ Senior Specialist - SAS Programming


Your Job

  • 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

Your Profile

  • Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
  • A minimum of 4 years of total experience with a at least 2 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
  • 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)



If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:


Ms Vineeta Bisht
Manager, Human Resources India