Statistical Programmer II
- Experience Level
- Experienced (non-manager)
At PRA, we know that our people are our greatest strength, so we work hard to hire the very best.
If you join our team, you can expected to be challenged, rewarded and nurtured.
We have a dynamic and loyal workforce, a culture that values individuality and innovation and an ongoing commitment to employee growth and development.
The result? A dynamic and loyal workforce who take pride in the their work on clinical development which changes lives.
As a home-based Clinical Programmer you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.
Working closely with Data Managers and Clinical Data Standards teams, your main responsibilities will include:
- Providing expertise, delivery and oversight of clinical programming deliverables from study set-up to submission-ready tabulation packages.
- Providing specifications for data models to be used for quality review and for final data model (SDTM); design mapping algorithms for non-standard conversions.
- Ensuring quality review of datasets (e.g. Pinnacle 21 compliance checking); ensuring datasets are available for stakeholder use (medical review, central monitoring, adaptive designs) and compliant for database lock.
- Program, or oversee Programming of, quality review checks and reports for use by Data Managers and other team members.
- Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL)
- Creation of submission-ready SDTM packages for FDA or other regulatory authorities
- Acquiring and maintaining working knowledge in data collection tools such as Medidata Rave, LSAF, Pinnacle 21
- Working to CDISC standards such as SDTM, CDASH, Controlled Terminology and define.xml.
Technically capable, a strong communictor, highly organized and possess first class project management skills!
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- Bachelors Degree or higher/equivalent in Computer Science, Data Science, Data Engineering, Mathematics or another relevant Scientific field.
- Clinical Programming experience and experience working on a clinical trial
- Expert knowledge of SAS Programming, Define.xml, SDTM aCRF, cSDRGs
- Expert knowledge of data structures
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.