Statistical Programmer II

Everest Clinical Research

1d•Remote

About The Position

Everest Clinical Research is a global Clinical Research Organization that proudly maintains a regional clinical operations hub in Warsaw. Now, Everest's global biometrics team is embarking on an exciting phase of growth, and we're thrilled to announce the biometrics team’s expansion in Poland with the establishment of a dedicated biometrics group. Over the next 6 months, Everest plans to build a dynamic team of 20 talented professionals who are passionate about biometrics. If you’re driven by data, eager to make a meaningful impact, and want to be part of a Statistical and Data Management Center of Excellence, we invite you to join our global biometrics team and help shape the future of clinical research. 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 II remotely from a home-based office near Warsaw, Poland in accordance with our Work from Home policy.

Requirements

A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences
At least two years’ experience in clinical trial statistical programming and/or data analysis.

Responsibilities

Develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRFs), and other related programming documentation (e.g., define.xml files, reviewers’ guides for SDTM and ADaM datasets) based on Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), which are compliant to the pharmaceutical clinical research industry standards, conventions, regulatory requirements, and Sponsor-specific requirements.
Program and validate SDTM and ADaM datasets following approved dataset specifications, these may include datasets for Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), and other data analysis and reporting needs such as ad hoc and exploratory data analyses.
Develop SAS programs to generate and validate statistical output reports of trial data based on the Statistical Analysis Plan and statistical TLGs mock-up shells.
Develop and test SAS programs for clinical trial database logical checks and reports for ongoing data review.
Document data and programming information in accordance with Everest company SOPs and WIs; 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.
May lead programming efforts for assigned projects.
May participate in the development and maintenance of clinical trial data and statistical reporting standards to ensure that the company standards are up-to-date and in-line with pharmaceutical industry standards, conventions, and regulatory requirements.
Provide technical guidance and support to less experienced Statistical Programmers in the study teams.
Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, and 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.