Senior Statistical Programmer

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

Benefits offered by this job

Medical, dental, and vision coverage

Life & AD&D insurance

Disability insurance

Tuition reimbursement

Fitness reimbursement

Employee Assistance Program

Pension plan

Generous paid time off

Job summary

Everest Clinical Research invites applications for a Senior Statistical Programmer role in Toronto/Markham, Ontario on-site or remotely from anywhere in Canada under the Work from Home policy.

The position requires a Master’s/PhD in Statistics or related fields (or a Bachelor’s with 6+ years) and extensive experience in clinical trial statistical programming, SDTM/ADaM, QC, and regulatory deliverables.

Qualifications

• Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences with 4+ years in clinical trial statistical programming.
• Bachelor’s degree with 6+ years in clinical trial statistical programming.

Responsibilities

• Lead programming projects and ensure on-time delivery with quality for statistical deliverables.
• Develop SDTM and ADaM datasets and define.xml specifications; perform QC reviews.
• Program and validate datasets, perform CDISC checks, and resolve Pinnacle 21 issues.
• Support regulatory submissions and mentor junior programmers.

Skills

Statistical programming

Clinical trials

QC/validation

SDTM/ADaM

Education

Master's or PhD in Statistics/Biostatistics/Epidemiology/CS

Bachelor's in Statistics/Biostatistics/CS

Tools

Pinnacle 21

CDISC SDTM/ADaM

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.