Statistical Programmer I

Everest-Clinical-Research; Markham; Hybrid; CAD 62,000 - 76,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Pension plan

Performance bonus

Job summary

Everest Clinical Research is seeking a Statistical Programmer I to develop and validate SDTM/ADaM datasets, write SAS programs, and support regulatory reporting. The role combines on-site work in Toronto/Markham with remote options from anywhere in Canada under the work-from-home policy.

Ideal candidates hold a Master’s or PhD in statistics or related fields with SAS Base/Advanced certification, and have experience in clinical trial data programming and data cleaning.

Qualifications

• Master’s or Ph.D. in statistics/biostatistics or related field with SAS certification.
• Clinical trials programming experience and data analysis desirable.

Responsibilities

• Develop and review SDTM/ADaM datasets and related docs per SAP and SOPs.
• Program and validate SDTM/ADaM datasets and perform conformance checks.
• Create SAS programs to generate statistical outputs for trial data.
• Support clinical study reports and safety/efficacy data integrations.

Skills

SAS programming

CDISC SDTM/ADaM

Data integrity checks

Statistical programming

Education

Master’s or PhD in statistics/biostatistics/epidemiology/related field

SAS Base/Advanced certification

Tools

SAS

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.

Statistical Programmer I

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.

Accountabilities

Statistical Programming:

• Under supervision, may develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents (e.g., define.xml, reviewer’s guide) based on Statistical Analysis Plan (SAP), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements.
• Program and validate SDTM and ADaM datasets following approved dataset specifications; perform CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings.
• Develop SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock-up shells.
• Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g. Development Safety Update Report, 120 Day Safety Update, etc.), ad-hoc requests, and exploratory data analyses.

2. Clinical Data Acquisition and Cleaning Support:

• Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review.
• Support data acquisition of non-CRF data by developing SAS programs to reconcile the CRF and non-CRF data and performing data integrity checks of the non-CRF data.
• Develop SAS programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.).
• Develop SAS programs to generate Patient Profiles to support trial subject case review activities.

Document data and programming information in accordance with Everest company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.

Achieve a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators.

Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements when applicable.

Comply to Everest company-specific and clinical trial Sponsor-specific training requirements.

Develop and provide expertise in other programming and system administration areas when required.

Requirements

A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, or computer sciences, with SAS certified Base/Advanced. Clinical trials programmers are highly preferred; exposure/experience in clinical trial statistical programming and/or data analysis is desirable.

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: $45,000 - $55,000.

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.