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Job Title : Principal Statistical Programmer (Remote)
Job Location : Bridgewater NJ USA
Job Location Type : Remote
Job Contract Type : Fulltime
Job Seniority Level : MidSenior level
Everest Clinical Research (“Everest”) is a fullservice contract research organization (CRO) providing a broad range of expertisebased clinical research services to worldwide pharmaceutical biotechnology and medical device industries. We serve some of the bestknown 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 fullservice 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 customerfocus 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 customerfocused individuals to join our winning team as Principal Statistical Programmer for our Bridgewater New Jersey USA onsite location or remotely from a homebased office anywhere in the USA in accordance with our Work from Home policy.
Key Accountabilities :
- Lead projects with higher level of complexity / challenges / difficulties. Lead efforts to resolve complex statistical programming issues or problems.
- 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.
- 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.
- 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.
- Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
- Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
- Perform 3rd level QC review on programming deliverables before their release to the clients.
- Perform QC review / assessment on regulatory submission programming documents datasets tables / listings / graphs (TLGs) and computer programs etc.
- May lead programming efforts for drug development programs or for assigned client clusters.
- Provide training mentorship and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform 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 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 :
To find out more about Everest Clinical Research and to review other opportunities please visit our website at
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.
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link.
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Key Skills
Business Development,Customer Service,Attorney,CISSP,Data Analysis
Employment Type : Full Time
Vacancy : 1
