Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater, New Jersey, USA, Taipei, Taiwan, and Shanghai (Pudong Zhangjiang New District), China.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Associate Director, Statistical Programming for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. **
Key Accountabilities**
- Provide leadership/expertise in resolving complex problems in support of division/company objectives, assigned projects, or as a consultant to others.
- Represent the company and the statistical programming department in customer development and liaison.
- Lead assigned projects by applying management skills and regulatory standards and requirements.
- Allocate workload and resources according to study/project needs.
- Ensure quality control and quality assurance by overseeing study teams’ work and meeting with the study teams on a one-on-one basis.
- Monitor timelines for programming area activities for assigned projects.
- Develop training matrix and coordinate and schedule technical training and SOP training through monthly programmer meeting.
- Provide statistical programming support to assigned studies.
- Develop and maintain clinical trial data and statistical reporting standards in line with pharmaceutical industry standards and conventions.
- Assist in developing statistical programming Standard Operating Procedures and guidelines.
- Develop and implement statistical programming good working practices.
- Assist in recruiting and developing of statistical programmers.
- Provide technical training to programmers and biostatisticians.
Qualifications And Experience
- M.Sc. or higher degree in Computer Science, Biostatistics, Mathematics or related field.
- 8 years' hands-on, related experience.
- In-depth knowledge of clinical trial data management, statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. In-depth knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
- Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to Food and Drug Administration. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required in order to build the standardization portfolio.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
| -1
