Statistical Programmer

Everest Clinical Research Corporation; Bridgewater (MA); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical-Dental-Vision

Life Insurance

Disability Insurance

Tuition Reimbursement

Fitness Reimbursement

Employee Assistance Program

401(k)

Paid Time Off

Job summary

Everest Clinical Research Corporation is seeking a Statistical Programmer to support SDTM/ADaM dataset development, SAS programming, and regulatory deliverables within a dynamic CRO environment. The role offers on-site work in Bridgewater, NJ or remote work from anywhere in the USA under our Work from Home policy.

The candidate will contribute to data standardization, reporting, and data cleaning while maintaining audit readiness and regulatory compliance.

Qualifications

• Master’s or higher in statistics, biostatistics, or related field; 2+ years clinical trial programming experience.
• Working knowledge of SAS, R, SQL, and Excel.
• Must pass SAS-based assessment test.
• May work remotely from other US locations.
• Multiple openings.

Responsibilities

• Develop and validate SDTM and ADaM datasets per SAP/SOPs/WIs.
• Create SAS programs to generate tables, listings, and graphs.
• Support Clinical Study Reports and safety data integrations.
• Ensure data integrity and audit readiness throughout trials.
• Address data issues with Data Managers and QC teams.

Skills

Biostatistics

Statistical programming

Data analysis

Education

Master’s or higher in statistics/biostatistics

Tools

SAS

R

SQL

Excel

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 Statistical Programmer 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.

Key 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.
• 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.

Qualifications and Experience:

• A Master’s or higher in statistics, biostatistics, or a related quantitative field, with at least two years of experience in clinical trial statistical programming. Working knowledge of SAS, R, SQL, Excel. Must pass a SAS-based assessment test. May work remotely from other US locations. Multiple openings.

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 401(k) retirement
• generous paid time off and sick leave
• the opportunity to earn a performance based bonus

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.