Associate Director, Statistical Programming
Company: Everest Clinical Research
Location: Bridgewater
Posted on: April 2, 2026
|
|
|
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 (Greater New
York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New
District), China and Taipei, Taiwan. 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 Associate Director, Statistical Programming 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. Job Accountabilities: Work with a Director, Senior
Director, and/or Executive Director of Biostatistics/Biometrics to
manage clinical trial programs/projects from one or multiple
clients. Provide day-to-day technical and operational leadership to
project teams supporting these programs/projects. Represent the
company and the Statistical Programming department in business
development and client relationship management initiatives. Provide
leadership and oversight to the assigned client programs/projects;
ensure quality, timely, and within budget deliveries. Follow-up on
the industry trends in data and programming standards and good
programming working practices. Follow-up on the latest
technologies, consult with clients, upper management, peers, and
subordinates to evaluate, recommend, and implement improvements to
the existing company standards and good working practices. Develop
and maintain clinical data and statistical reporting standards in
line with pharmaceutical industry standards and conventions. Coach,
mentor, develop, and provide technical review, advice, and
expertise to direct subordinate Statistical Programmers, as well as
indirect subordinate Biostatisticians and Statistical Programmers
assigned to the program/projects. Perform semi-annual and annual
performance review and create developmental plans for direct
subordinates and, where appropriate, indirect subordinates by
contributing to the performance evaluation process. When required,
serve as a principal level Statistical Programmer, working
effectively with interdisciplinary teams to contribute
strategically (through innovative ideas or applications) to drug
development and commercialization at the study and drug
compound/therapeutic areas levels. Perform quality control (QC)
review of statistical programming deliverables, including
documentation, before they are released for production, delivered
to clients, or submitted to regulatory agencies. These QC
activities may include, but are not limited to, the following:
Review and confirm SDTM dataset specifications. Perform QC
activities on SDTM datasets programmed by other Statistical
Programmers and Biostatisticians. Review and confirm ADaM dataset
specifications. Perform QC activities on ADaM datasets programmed
by other Statistical Programmers and Biostatisticians. Perform
overall review of statistical tables, listings, and figures (TLFs).
Review and confirm define documents and reviewer’s guides for SDTM
and ADaM datasets. When required, review and provide input to
clinical data management deliverables including, but not limited
to, the following: electronic Case Report Forms (eCRFs), eCRF
Completion Instructions, data validation specifications, Data
Review Plan (Plan; and the ongoing data review TLFs in accordance
with the Plan), and Data Management Plan (DMP). Contribute to
organization development and growth by participating in the
interview and evaluation process for professional applicants.
Qualifications: Must have at least a bachelor degree and preferred
to have M.Sc., M.A. or higher in Statistics, Computer Science, or
relevant fields with at least 14 years of clinical research
experience. Requires demonstrated experience and success in leading
statistical programming teams in planning and implementing
statistical programming project plans, leading programming teams to
generate and deliver quality and timely deliverables within budget.
Requires demonstrated experience implementing CDISC standards to
specify, program, and validate SDTM and ADaM-compliant databases
for numerous therapeutic areas. Requires demonstrated experience
supporting electronic regulatory submissions of clinical trial data
for individual studies and integrated safety and efficacy analyses.
Experience with multiple regulatory agencies preferred (FDA, PMDA,
etc.). Experience with developing and delivering training curricula
and governing documents (Standard Operating Procedures, Work
Instructions, Templates, etc.) preferred. Must have an in-depth
knowledge of clinical trial data management, statistical
programming and analysis, requirements for assembling and
presenting trial results to regulatory agencies. Exceptional people
management skills with ability to interact successfully and
communicate effectively with personnel at all levels within the
organization and with client contacts. Exceptional written
communication and presentation skills. Travel level specification:
This position may require up to 10% business travel. 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 / pension plan,
generous paid time off and sick leave, and the opportunity to earn
a performance based bonus. Estimated Salary Range: $170,000 -
$205,000. 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. LI-Remote |
LI-TK1 INDHP
Keywords: Everest Clinical Research, Westport , Associate Director, Statistical Programming, Science, Research & Development , Bridgewater, Connecticut