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Manager Remote Statistical Programmer Jobs in New Jersey

Remote or field-based positions will have different workplace arrangements which will be indicated ... Weight management programs * Gastrointestinal health program * Substance use management program

... scientists, statistical programmers, data managers, regulatory, and clinical operations ... Depending upon location, this role will be hybrid or remote and will require some travel as ...

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Manager Remote Statistical Programmer information

What is the difference between Manager Remote Statistical Programmer vs Senior Statistical Programmer?

AspectManager Remote Statistical ProgrammerSenior Statistical Programmer
ResponsibilitiesOversees project teams, manages timelines, and ensures regulatory compliancePerforms complex statistical programming tasks, mentors junior staff
Required SkillsLeadership, project management, advanced programmingAdvanced programming, statistical analysis, problem-solving
Work EnvironmentTeam management, client interaction, cross-functional collaborationIndividual contributor, project-focused
CertificationsLikely to have SAS or CDISC certifications, leadership trainingSAS certifications, statistical programming expertise

The main difference is that the Manager Remote Statistical Programmer focuses on team leadership and project oversight, while the Senior Statistical Programmer primarily handles complex programming tasks and technical expertise. Both roles require strong SAS skills and industry experience, but the managerial position involves additional responsibilities in team management and strategic planning.

What are common challenges faced by a Manager Remote Statistical Programmer, and how can they be addressed?

A Manager Remote Statistical Programmer often encounters challenges such as coordinating geographically dispersed teams, ensuring data security, and maintaining effective communication. Addressing these requires leveraging robust project management tools, implementing clear protocols for data handling, and fostering regular virtual team meetings to discuss progress and resolve issues. Building a strong remote culture and providing ongoing training also help in keeping the team engaged and aligned with project goals.

What are the key skills and qualifications needed to thrive as a Manager Remote Statistical Programmer, and why are they important?

To thrive as a Manager Remote Statistical Programmer, you need expertise in statistical programming (typically SAS or R), clinical trial data analysis, and a degree in statistics, mathematics, or a related field. Familiarity with CDISC standards, regulatory submission requirements, and experience using clinical data management systems are essential, along with relevant certifications like SAS Certified Advanced Programmer. Strong leadership, effective communication, and problem-solving skills are crucial for managing remote teams and collaborating across departments. These skills ensure robust data analysis, regulatory compliance, and efficient project delivery in a remote and highly regulated environment.

What is a Manager Remote Statistical Programmer?

A Manager Remote Statistical Programmer is a professional who oversees a team of statistical programmers, often within the pharmaceutical, biotechnology, or clinical research industries, while working remotely. Their responsibilities include managing programming projects, ensuring data analysis and reporting adhere to regulatory standards, and supporting the development of statistical analysis plans. They also mentor team members, coordinate timelines, and communicate with cross-functional teams to ensure successful project delivery. Remote managers use technology to collaborate effectively with their teams and clients from different locations.
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Principal Statistical Programmer (Remote)

Everest Clinical Research

Bridgewater, NJ โ€ข On-site, Remote

$112K - $175K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago


Job description

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 Principal Statistical Programmer 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:
  1. Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
  2. Perform 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.
  3. Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers' skills and expertise, as well as availability.
  4. 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.
  5. Perform 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.
  6. Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
  7. Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
  8. Perform 3rd level QC review on programming deliverables before their release to the clients.
  9. Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
  10. May lead programming efforts for drug development programs or for assigned client clusters.
  11. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
  12. Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.
  13. May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.
  14. Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.
  15. Participate in statistical programming project bidding or bid defense meetings.
  16. Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors.

Qualifications and Experience:
  1. M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
  2. 10 (M.Sc., M.A.)/9 (Ph.D.) years' related experience.
  3. 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.
  4. 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. 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.

Benefits & Compensation:
We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision 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 Range: $112,000 - $175,000
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.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.
#INDHP
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.