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.
To find out more about Everest Clinical Research and to review other
opportunities, please visit our website at www.everestclinical.com
[http://www.ecrscorp.com].
Estimated Salary Range: $112,000 - $175,000
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