Clinical SAS Programmer

2 weeks ago

Mumbai, India mercury connections Full time

Good knowledge of GCP Good Programming Practices ICH-E3 ICH-E9 and other regulatory guidance documents (e.g. USFDA and EMEA)
Good understanding of the statistical programming domain and related processes
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/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.
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
Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹500,000.00 - ₹700,000.00 per year

**Benefits**:

- Health insurance
- Paid sick time

Schedule:

- Day shift
- Morning shift
- Weekend availability

**Experience**:

- total work: 1 year (preferred)

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