Everest Clinical Research Services Inc.
Senior Manager, Statistical Programming
Everest Clinical Research Services Inc., Trenton, New Jersey, United States,
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 (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.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.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 remotely anywhere in the USA as a
Senior Manager, Statistical Programming
or in our Bridgewater, New Jersey, USA on-site location.Key Accountabilities:Coach, mentor, develop, provide technical review, advice and expertise to direct subordinate Statistical Programmers as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.Participate in the development and maintenance of standards for database design by defining standard database modules, variable names, attributes, and associated data validation/logical checks.Participate in the development and maintenance of standards for SAS datasets of clinical trial data, including but is not limited to, raw and derived datasets from Everest databases or acquired from sponsors or 3rd party vendors.Perform a leadership role in statistical programming and reporting with focuses on planning and execution of programming tasks involving standardized summary tables, listings, and graphs using established standard mockups and SAS programs/macros.Lead programming efforts for assigned client clusters.Provide mentorship and technical supervision to the statistical programming project team members of responsible projects.Follow up on the industry trends in data and programming standardization, and good programming working practices.Participate in the development of statistical programming SOPs, guidelines, and good working practices.Assist in recruiting and developing of statistical programmers.Provide initial orientation training to Statistical Programmers and Biostatisticians.Lead the efforts to plan and execute archiving of the statistical programming information upon completion of the project and transfer of the archives to the sponsor.Perform the job accountabilities of a Principal Statistical Programmer, and assist statistical programming management in managing statistical programming projects.Lead projects with higher level of complexity/challenges/difficulties.Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials.Create SDTM mapping specifications and ADaM data specifications.Perform 3rd level QC review on programming deliverables before their release to the clients.May lead programming efforts for drug development programs or for assigned client clusters.Participate in statistical programming project bidding or bid defense meetings.Qualifications and Experience:M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.Minimum 9 years' experience with in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.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.
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Senior Manager, Statistical Programming
or in our Bridgewater, New Jersey, USA on-site location.Key Accountabilities:Coach, mentor, develop, provide technical review, advice and expertise to direct subordinate Statistical Programmers as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.Participate in the development and maintenance of standards for database design by defining standard database modules, variable names, attributes, and associated data validation/logical checks.Participate in the development and maintenance of standards for SAS datasets of clinical trial data, including but is not limited to, raw and derived datasets from Everest databases or acquired from sponsors or 3rd party vendors.Perform a leadership role in statistical programming and reporting with focuses on planning and execution of programming tasks involving standardized summary tables, listings, and graphs using established standard mockups and SAS programs/macros.Lead programming efforts for assigned client clusters.Provide mentorship and technical supervision to the statistical programming project team members of responsible projects.Follow up on the industry trends in data and programming standardization, and good programming working practices.Participate in the development of statistical programming SOPs, guidelines, and good working practices.Assist in recruiting and developing of statistical programmers.Provide initial orientation training to Statistical Programmers and Biostatisticians.Lead the efforts to plan and execute archiving of the statistical programming information upon completion of the project and transfer of the archives to the sponsor.Perform the job accountabilities of a Principal Statistical Programmer, and assist statistical programming management in managing statistical programming projects.Lead projects with higher level of complexity/challenges/difficulties.Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials.Create SDTM mapping specifications and ADaM data specifications.Perform 3rd level QC review on programming deliverables before their release to the clients.May lead programming efforts for drug development programs or for assigned client clusters.Participate in statistical programming project bidding or bid defense meetings.Qualifications and Experience:M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.Minimum 9 years' experience with in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.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.
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