Location: Durham, NC
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech
- 5-10+yrs of SAS programming experience, preferably in UNIX environment, supporting clinical trials data analysis. Enterprise Guide experience is a plus.
- Solid CDISC Standards knowledge, 8+ years of ADaM programming experience supporting safety and efficacy analysis. Neuroscience TA experience is preferable but not required.
- Well experienced in converting information from aCRF, SDTM data, SAP and SPP into ADaM specifications and review TLF outputs from vendors.
- Experienced in supporting ISS, ISE ADaM programming and submissions.
- Ability to quickly learn internal macros, processes and interpret Pinnacle 21 results.
- Team player with excellent communication skills and experience working with stat programmers, statisticians and data management personnel.
- Develop SAS programs for SDTM, ADaM, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
- Provide technical planning to include overseeing the set-up of key macros and SAS programs.
- Act as a Lead Programmer for projects.
- Represent Statistical Programming at internal and client meetings.
- Act as a Statistical Programming consultant to clients and internal customers in related disciplines e.g. Clinical Data Management, Project Management and Medical Writing.
- Demonstrate excellent problem-solving skills, a proactive approach and a willingness to make decisions on a regular basis.
- Ensure quality of personal work and the work of the team when acting as a Lead Programmer.
- Prioritize personal workload and that of teammates; perform work with minimal supervision.
- Work on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity.
- Advise Senior Statistical Programming Staff of changes in scope of projects to enable the timely development of change orders.
- Good experience with CDISC standards including Define.xml files.
- Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment.
- Review draft and final production runs for project to ensure quality and consistency.
- Represent Statistical Programming during client audits ensuring study documentation is maintained and filed according to Covance processes.
- Assist with interviewing and selection of potential candidates.
- Carry out all activities according to Covance SOPS working within the framework of the Quality management System and to Good Clinical Practice (GCP).
- Provide ongoing training and mentoring within Statistical Programming to ensure thorough knowledge of the processes used and the ongoing technical development.
- Perform other duties as requested by management.
- BSc in a computing, life science, mathematical or statistical subject.
- A high computing content is considered to be beneficial; however proven computing skills are most important.
- Alternative academic qualifications or experience are assessed to ensure equivalent background.
- Knowledge in all aspects of clinical trials from initial study set-up to study completion.
- Full knowledge and understanding of the processes and procedures used within a Statistical Programming environment.
- Able to identify training and development needs, opportunities for optimizing staff utilization and employing the most efficient practices.
- Excellent organizational skills and the ability to delegate and prioritize work to meet tight deadlines while maintaining high standards.
- Self motivation and ability to work independently with minimum direction.
- Excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work.
- Good interpersonal skills and the ability to communicate appropriately withal levels of staff and confidently with other disciplines and external clients.
- A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them.
- A co-operative and team orientated approach.
- Team leadership experience, as demonstrated by ability to organize and motivate project teams.
Apply on company website