"Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA."
This role will offer you the flexibility to work 1 day a week from the comfort of your home and you will benefit from fitting this job to your availability - full-time or part-time.
Our clients Data Center of Excellence is committed to delivering 10 years of completed clinical trials data to the organization as anonymized SDTM datasets. The majority of the source data is in legacy standard and as such requires thoughtful transformation/anonymization and complex QC achieved through a hybrid of automated and manual checks. As business processes and enabling systems have changed over the 10 year period we are finding some of the standard profiling checks around data completeness are failing and require further investigation before the studies can be processed. The following is an indicative list of the types of activities where support is required:
* Profile data failures for common patterns across studies, datasets and/or variable (note failures may be in Excel reports and/or HDFS-Impala tables)
* Access/Assess actual study data to confirm root cause for failure and develop business rule/work around for processing the data (note study data may be in SAS datasets or HDFS-Impala tables)
* Merge/Prep datasets for processing (SAS)
* Work with Data Center of Excellence and other 3rd party vendors to refine profiling checks and automate business rules
* Confirm anonymization detection algorithms are working as expected via programmatic and/or manual QC
* Provide input into future requirements based on learnings
* Identify opportunities to influence upstream DM/Stats processes to streamline future profiling
* 3 years' experience with data management and/or statistics systems and processes
* Knowledge of CDISC SDTM standards
* Basic SAS/SQL skills
* Aptitude for root cause analysis and problem solving
* Good communication skills
* Passion for interrogating data