Senior SDTM Programmer

ICON plc

5 - 10 years

15 - 20 Lacs

bengaluru

Posted:6 days ago| Platform:

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Skills Required

cdisc sdrg sdtm

Work Mode

Remote

Job Type

Full Time

Job Description

Shift: 2pm - 11pm IST (Remote)

Role & responsibilities

Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
Program reports and listings as requested by project team members for ongoing studies.
Develop transfer specifications with vendors for external data sources.
Perform consistency checks on data transferred between client and external parties to ensure completeness and accuracy of data contained transfers.
Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format
Perform Quality Control (QC) on programming work performed by fellow Database Programmers.
Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency

MUST HAVE Skillsets:

Bachelors degree OR certification.
Minimum of 5 years
of clinical SAS programming experience in the pharmaceutical industry.
Working knowledge of CDISC
SDTM
mapping/specs/conversion/domains/datasets/eCRF/eCRT
Package/define.xml, SDRG
development and
SDTM
data transfer operations on clinical studies.
Understanding of regulatory requirements relevant to submissions.
Knowledge of clinical trial study design and electronic data submission requirements.

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