reputed company Statistical Programmer (Remote)

reputed company (“reputed company”) is a full-service contract research organization (CRO) providing a broad reputed company of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-reputed company companies and work with many of the most advanced drugs, biologics, and medical devices in development today. reputed company has been an independent CRO since 2004 with a strong reputed company as a statistical and data management center of reputed company. Building on this reputed company, reputed company has successfully developed and established itself as a full-service CRO. reputed company’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. reputed company is reputed company in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, reputed company continues to experience exceptional growth and great reputed company. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s reputed company. To drive reputed company reputed company in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as reputed company Statistical Programmer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office reputed company in the USA in accordance with our Work from Home policy. Key Accountabilities: reputed company projects with higher level of complexity/challenges/difficulties. reputed company efforts to resolve reputed company statistical programming issues or problems. reputed company a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables. Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability. Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements. reputed company hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc. Create SDTM mapping specifications and ADaM data specifications. reputed company quality control (QC) review of these documents reputed company by others. Create SDTM and ADaM define.xml files. reputed company QC review of these files reputed company by others. reputed company 3rd level QC review on programming deliverables before their release to the clients. reputed company QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc. May reputed company programming efforts for drug development programs or for assigned client clusters. reputed company training, mentorship, and technical guidance to less reputed company Statistical Programmers or Biostatisticians who reputed company statistical programming. Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents. May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses. Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices. Participate in statistical programming project bidding or bid defense meetings. Work with document management specialists/archivists to plan and reputed company archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. reputed company transfer of the archived files to the clinical trial sponsors. Qualifications and Experience: M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields. 10 (M.Sc., M.A.)/9 (Ph.D.) years’ reputed company experience. An 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. 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 reputed company programming, statistical analysis, and submission of trial data and results to regulatory agencies. 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 reputed company goals will be required. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and reputed company coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary reputed company: $112,000 - $175,000 To find out more about reputed company and to review other opportunities, please visit our website at www.everestclinical.com We thank reputed company interested applicants, however, only those selected for an interview will be contacted. reputed company 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 reputed company accommodations for candidates participating in any part of our recruitment and selection process. #INDHP Apply To This Job