Statistical Programmer

Everest Clinical Research Corporation; United States; Hybride; USD 104 000 - 128 000; Plein temps

Avantages offerts par ce poste

401(k) retirement plan

Tuition reimbursement

Medical, dental, and vision coverage

Paid time off and sick leave

Résumé du poste

Everest Clinical Research Corporation in Bridgewater, NJ, is seeking a Statistical Programmer to design and validate SDTM/ADaM datasets, generate reports, and support regulatory submissions. The role allows on-site work in New Jersey or remote work from anywhere in the USA under the Work from Home policy.

The ideal candidate holds a Master’s in statistics or biostatistics with 2+ years in clinical trial programming and is proficient in SAS, R, SQL, and Excel, with SAS assessment required.

Qualifications

• Master’s degree in statistics/biostatistics with at least two years in clinical trial programming.
• Working knowledge of SAS, R, SQL and Excel.
• Must pass SAS-based assessment test.
• Remote work from within the US permitted.

Responsabilités

• Develop and review SDTM and ADaM datasets per SAP and SDTM/ADaM standards.
• Program and validate datasets and generate statistical output reports.
• Support Clinical Study Reports and data integrations including safety and efficacy.
• Ensure audit readiness and maintain documentation per SOPs.

Connaissances

SAS

R

SQL

Excel

Formation

Master's in Statistics/Biostatistics

Outils

SAS

R

SQL

Excel

Description du poste

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

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

Estimated Salary: $116,000

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.