Qureos Mentor

Venesco, LLC

<div>Description:

SAS Programmer 
Venesco is seeking skilled SAS Programmers to develop validated statistical programs and CDISC-compliant datasets to support clinical trials, statistical analyses, safety reporting, and FDA submissions.
Requirements:

 Duties and Responsibilities<ul><li>
Develop and validate SAS programs.</li><li>
Produce Tables, Listings, and Figures (TLFs).</li><li>
Generate SDTM, ADaM, and SEND datasets.</li><li>
Develop define.xml files and reviewer guides.</li><li>
Create programming validation plans and reports.</li><li>
Develop randomization programs and statistical outputs.</li><li>
Support interim and final analyses.</li><li>
Assist with FDA submission packages.</li><li>
Collaborate with Clinical Data Management and Biostatistics teams.</li><li>
Maintain programming documentation and standards.</li></ul>
Minimum Qualifications<ul><li>
Bachelor's degree in Statistics, Computer Science, Mathematics, or related field.</li><li>
SAS Advanced Programmer Certification required.</li><li>
Minimum 7 years of clinical SAS programming experience.</li><li>
Extensive experience with CDISC, SDTM, and ADaM standards.</li><li>
Experience supporting FDA submissions.</li><li>
Strong knowledge of validation practices and regulatory requirements</li></ul>
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.</div>

SAS Programmer

<div>Description:

 Clinical Database Developer
Venesco LLC is seeking a Clinical Database Developer to serve as the technical lead for the design, development, testing, validation, implementation, and maintenance of clinical trial databases supporting FDA-regulated medical product development programs. The individual ensures clinical databases meet FDA regulatory requirements, ICH guidelines, Good Clinical Data Management Practices (GCDMP), and CDISC standards, while supporting data collection, quality control, and regulatory submissions.
Requirements:

Duties and Responsibilities<ul><li>
Develop, configure, test, validate, implement, and maintain study-specific electronic data capture (EDC) databases.</li><li>
Create and maintain CDASH-annotated Case Report Forms (CRFs).</li><li>
Develop database specifications and validation documentation.</li><li>
Perform User Acceptance Testing (UAT) and system validation activities.</li><li>
Implement edit checks, derivations, and quality control procedures.</li><li>
Support database change management and version control processes.</li><li>
Generate data extracts, listings, and reports.</li><li>
Collaborate with Clinical Trial Managers, Data Managers, SAS Programmers, and Biostatisticians.</li><li>
Ensure compliance with FDA regulations, ICH E6, GCDMP, CDISC/CDASH, and SDTM standards.</li><li>
Support database lock activities and preparation of submission-ready datasets.</li></ul>
Minimum Qualifications<ul><li>
Bachelor's degree in Computer Science, Information Systems, Health Informatics, Clinical Research, or related field.</li><li>
Minimum 5 years of clinical database development experience.</li><li>
Experience with EDC systems and clinical trial databases.</li><li>
Knowledge of FDA-regulated clinical research and CDISC standards.</li><li>
Ability to obtain required DoD security credentials.</li><li>
CompTIA Security+ certification or ability to obtain within required timeframe.</li></ul>
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.</div>

Clinical Database Developer

<div>Description:

Clinical Research Associate
Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight support to ensure studies are conducted in compliance with protocols, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and sponsor requirements.
Requirements:

Duties and Responsibilities<ul><li>
Conduct site qualification, initiation, monitoring, and closeout visits.</li><li>
Perform source data verification (SDV).</li><li>
Review informed consent documentation and study records.</li><li>
Evaluate protocol compliance and identify deviations.</li><li>
Review regulatory binders and essential documents.</li><li>
Generate clinical monitoring reports and follow-up letters.</li><li>
Support site training and communication activities.</li><li>
Track and assist with CAPA implementation.</li><li>
Support audit and inspection readiness.</li><li>
Maintain study documentation and monitoring files.</li></ul>
Minimum Qualifications<ul><li>
Bachelor's degree in Life Sciences, Nursing, Public Health, or related discipline.</li><li>
Minimum 3 years of clinical monitoring experience.</li><li>
Knowledge of FDA regulations, ICH-GCP, and clinical research practices.</li><li>
Strong written and verbal communication skills.</li><li>
Ability to travel CONUS and OCONUS.</li></ul>
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.</div>

Clinical Research Associate

Join Venesco, LLC and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Venesco, LLC

About Company

SAS Programmer

Clinical Database Developer

Clinical Research Associate