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sas Clinical Trials Programmer -remote 🔥


Senior SAS Clinical Trials Programmer -Remote
  • Contract Duration 6 Months


Description And Responsibilities
  • Seeking a full-time Senior SAS Clinical Trials Programmer to work with our client, a Clinical Research Organization client.
  • This Consultant will be acting as programming lead on studies responsible for resourcing, communication with Statisticians, DM, vendors, and clients, and performing deliveries.
  • The client will provide analytical services in support of the customer's clinical research studies and FDA submission process.
  • Senior SAS Clinical Trials Programmer will provide programming/analytical support utilizing SAS as the primary programming language to create and manage the production of analysis reports, summary tables/listings, and graphs for clinical trials submitted to various regulatory bodies worldwide.
  • The Senior SAS Clinical Trials Programmer must have excellent communication skills and must be able to communicate about the techniques developed and results of analysis both to executives and other analysts in the organization.


Qualifications – Essential
  • Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology-related field.
  • 8+ years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry.
  • To perform the lead programming role, lead continuous improvement in the programming function's operating systems, and provide consultancy across the function
  • SAS certifications (Base, Advanced, etc.) are highly desired.
  • Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient
  • Familiarity with programming to generate summary statistics (mean, median, etc.) and complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).
  • CDISC data models are a necessity, especially SDTM then ADaM
  • CDISC knowledge
  • SDTM and ADaM dataset experience
  • Good written and spoken communications skills in English and thought-leadership skills.


Major Responsibilities/Activities:
  • Develop, test, and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures, and listings (TFL).
  • Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, and specification of tables, figures, and listings (TFL) shells.
  • Develop and review specifications for SDTM datasets and ADaM datasets for safety data, TFL shells, and other specifications, e.g. patient profiles, and OPS reports.
  • Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high-complexity studies.
  • Serve as a programming project lead on a complex study (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively.
  • Ensure the budget and scope of project work remain aligned.
  • Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF.
  • Be able to describe and explain Worldwide documentation and eTMF requirements.
  • Contribute to department process improvement including creating and testing standard SAS Macros, and maintaining the required validation documentation.
  • Provide consultancy to Clinical Data Managers, Statistical Programmers, and Biostatisticians on programming, clinical and analysis data standards (CDISC), and electronic data submission requirements.
  • Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure, and tools, collaboration with other internal and external parties, and the role of the statistical programmer.
  • Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical
  • Practice, clinical data management, clinical/statistical reporting, and regulatory submission requirements, etc.
  • Act as subject matter expert for internal and external quality audits and inspections.
  • Ensure all activities performed by the study team are in compliance with Worldwide 3 and sponsor quality requirements, and relevant ICH and regulatory authority standards, e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR).
  • Act as a mentor for junior department members


About the Company
  • Our client is the Largest autonomous vendor in the business intelligence market, and a leader in business analytics services and software. They help customers to improve performance and deliver value by making better decisions faster through innovative solutions. With the vision and mission to empower, transform, and inspire the world of data into intelligence with analytics.
  • The client is strongly committed to providing employee –empowerment to make a difference, significant work, and a world-class environment that inspires innovation.
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