Senior Statistical Programmer

Everest-Clinical-Research; Markham; Hybrid; CAD 90,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life Insurance

Disability insurance

Tuition reimbursement

Fitness reimbursement

EAP

Pension plan

Generous PTO

Job summary

Everest Clinical Research in Canada seeks a Senior Statistical Programmer for Toronto/Markham, Ontario, on-site, or remotely from a home-based office anywhere in Canada per Work from Home policy. You will lead SDTM/ADaM programming, create define.xml files, perform QC, and support regulatory submissions.

Required are advanced degrees in statistics or related fields with several years of clinical programming experience and strong knowledge of CDISC standards and Pinnacle 21 validation.

Qualifications

• Master's or Ph.D. in Statistics, Biostatistics, Epidemiology, and Computer Sciences with at least four years’ experience in clinical trial statistical programming.
• Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming.

Responsibilities

• Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables and improving efficiency.
• Lead projects by applying project management skills and statistical programming techniques for on-time delivery and client satisfaction.
• Develop SDTM and ADaM datasets and specifications following SOPs and project requirements; perform QC review of documents.

Skills

Statistical programming

CDISC standards

Project management

Quality control

Education

Master's or Ph.D. in Statistics/Biostatistics/Epidemiology/Computer Science

Bachelor's degree in related fields

Tools

Pinnacle 21

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 Senior Statistical Programmer for 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.

Key Accountabilities:

Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work.

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.

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) QC 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. Perform QC review of these files prepared by others.

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

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.

Qualifications:

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

OR

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

Everest is inviting candidates to apply for this existing vacancy.

Benefits & Compensation:

• 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
• the opportunity to earn a performance based bonus

Estimated Salary Range: $90,000 - $140,000.

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.