Principal Statistical Programmer

Everest Clinical Research Corporation; Markham; On-site; CAD 125,000 - 175,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

Pension plan

Paid time off

Performance bonus

Job summary

Everest Clinical Research Corporation in Toronto/Markham, Ontario, seeks a Principal Statistical Programmer. The role is on-site with the option to work remotely from anywhere in Canada under our Work from Home policy, and involves leading complex statistical programming projects and client submissions.

You will develop SDTM and ADaM datasets, perform QC, ensure CDISC standards, mentor junior programmers, and contribute to regulatory submissions. A Master’s or Ph.D.

Qualifications

• Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, and Computer Sciences with at least 8 years of clinical trial statistical programming experience.
• OR
• Bachelor’s in the above fields with at least 10 years of experience in clinical trial statistical programming.

Responsibilities

• Lead complex statistical programming projects and ensure on-time, high-quality deliverables.
• Represent the company in client interactions related to programming projects and regulatory matters.
• Develop SDTM and ADaM datasets per SOPs and project requirements; perform QC reviews.

Skills

Statistical programming

CDISC SDTM/ADaM

Regulatory submissions

Project leadership

Education

Statistics

Biostatistics

Epidemiology

Computer Science

Tools

SAS

Pinnacle 21

QC tools

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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and 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 Principal Statistical Programmerfor our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Job Accountabilities:

Lead projects with higher level of complexity/challenges/difficulties, and lead efforts to resolve complex statistical programming issues or problems.

Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business.

May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.

Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.

Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. Perform quality control (QC) review of these documents prepared by others.

Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.

Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) checklists.

Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.

Create SDTM and ADaM define.xml files, and table of contents. Perform QC review of these files prepared by others.

Participate and/or lead programming teams in support of product regulatory submission related activities.

Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.

Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities.

Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.

Complete job-required and project-specific training. Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs.

Document data and programming information in accordance with corporate SOPs and guidelines.

Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.

May lead programming efforts for assigned client clusters when required.

Qualifications:

A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least 8 years of experience in clinical trial statistical programming

OR

A Bachelor’s degree in the above fields with at least 10 years of experience in clinical trial statistical programming.

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 pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $125,000 - $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.