Overview:
As an SDTM Programmer you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities:
What you will be doing:
* Interact with vendors to receive CRF & external data. Review data transfer specs to ensure data is in a form we can use (SAS compliant variable names, follow Client standards and specific compound templates, file format is something we can use with little manipulation).
* Review CRF & external data received. Compare datasets and vendor annotated CRF to ensure all expect fields are captured - these datasets are then used to build the SDTM datasets.
* Write SAS programs to compare CRF data and External data (LAB, ECG, PK, EEG ) - compare subject id, visit, date, time, accession number. Reports are then given to data managers for reconciliation and to issue queries.
* Create Trial Design Domains based on protocol/CRF.
* Use a GUI interface (DSP) to create SDTM datasets. Using a series of boxes following arrows across the screen to layout the flow of data and the computations needed.
* This is "SAS-like" but is not using SAS directly to program the SDTM datasets. When you execute what is created in GUI environment, the system then writes SAS code to build the datasets. Takes some detective work to figure out what went wrong by looking at temporary and output datasets, and behind-the-scenes SAS code that gets written.
* Create SDRG and SDTM define
* QC SDTM datasets, specs, docs, annotations that other programmers create.
* Troubleshooting and SAS programming to create tools for the team - such as create a SAS programs to convert .csv/.xlsx/.dat files to SAS datasets. Or create programs to do full Proc Compare of a study's database (new data versus old data) that can be used as a standard across studies.
* Interacting with data managers, clinical programmers, statisticians, medical coders, external data vendors.
* Running Pinnacle 21 to validate SDTM datasets
Qualifications:
You are:
* Possessing a minimum 5+ years of experience with SDTM.
* At least 2+ years of trial lead experience preferably as the lead for a team of programmers OR At least 2+ years of experience developing SAS/R solutions that are implemented broadly across clinical programs or a therapeutic area.
* Having demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
* Having ability to communicate with cross-functional teams and gather feedback for study specifications and/or data issues. Experience reviewing and writing data specifications.
* Experienced working with CROs and reviewing work packages.
* Having high level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data
* Having demonstrated understanding of current industry standards for submission of clinical trial data
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