Statistical Programming Opportunities at Parexel
As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.
Senior/Principal Statistical ProgrammerJob ID post-40024712 Canada - Any Region - Home Based
You will provide technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, liaise with sponsors, Data Operations Leads, and other functional areas as required. In addition, the Principal Statistical Programmer can fill the Primary Statistical Programmer role on projects and liaise with sponsors, Data Operations Leads, and other functional areas as required. Furthermore, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.
•Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
•Lead a statistical programming team to successful completion of a study within given timelines and budget
•Monitor project resourcing, project budgets, and identify changes in scope
•Interact with Sponsors as the key contact with regard to statistical programming issues
•Provide technical support and advice to the internal team
•Check own work in an ongoing way to ensure first-time quality
•Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
QualificationsRequired skills and experience:
•Knowledge of the programming and reporting process
• At least 8 years of Statistical Programming experience for a Principal level role and 5+ years of experience for a Senior level role
• 5 plus years of proficiency in SAS programming
• 2+ years of ADaM, CDISC or SDTM
•Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
• Strong leadership ability with proven lead experience in a Pharma setting
•Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
• Attention to detail and excellent analytical skills
• Excellent communication skills (verbal and written)
•Competent in written and oral English.
•Excellent communication skills
Educated to degree level in a relevant discipline and/or equivalent work experience
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