Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior/Principal Statistical ProgrammerJob ID 60545BR 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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