FSP Principal Statistical Programmer (Remote)

FSP Principal Statistical Programmer (Remote)

Join to apply for the FSP Principal Statistical Programmer (Remote) role at Everest Clinical Research

FSP Principal Statistical Programmer (Remote)

4 days ago Be among the first 25 applicants

Join to apply for the FSP Principal Statistical Programmer (Remote) role at Everest Clinical Research

Get AI-powered advice on this job and more exclusive features.

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 Ontario, Canada with additional locations in : Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe.

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 FSP 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 :

• 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 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.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Research, Analyst, and Information Technology

Industries

Research Services, Pharmaceutical Manufacturing, and Hospitals and Health Care

Referrals increase your chances of interviewing at Everest Clinical Research by 2x

Sign in to set job alerts for "Statistical Programmer" roles.

Princeton, NJ $95,000.00-$110,000.00 1 week ago

Edison, NJ $99,461.00-$128,329.00 5 days ago

Whitehouse Station, NJ $67,600.00-$90,000.00 1 week ago

SAS Developer with AWS & ReactJS Experience - Remote

Analyst : Advanced Analytics and Data Science

Livingston, NJ $150,000.00-$200,000.00 3 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr