The company is a global leader in partnering with companies to transform and manage their business by harnessing the power of technology.
The role:
● Programs all tables, listings and graphs necessary for an assigned clinical study report (CSR).
● Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies.
● Writes code using Base SAS programs, SAS procedures, or standardized macros.
● Working knowledge of Oncology RECIST guideline, Leukemia studies preferred.
● Must know CDISC structure for ADaMs and SDTMs and follow ICH GCP guidelines.
● Experience working with ISS and ISE preferred.
● Should have excellent knowledge of using proc report and other SAS reporting tools.
● Should be able to identify data issues and communicate with DM/ Stat to resolve issues.
● Analyzes protocol, SAP, existing shells/templates as needed to understand structure and content of data.
● Perform data checks as needed, to ensure integrity and correctness of data displays.
● Prepare documentation for programs.
● Prepares documentation describing all datasets and variables within, including derived variables, and the project as a whole.
● Creates SAS datasets of clinical data from clinical databases.
● Should be able to work on safety ADaMs like but not limited to ADSL, ADAE, ADLB, ADEX, ADVS, ADEG and all other as well as efficacy datasets like ADRS, ADEFF, ADTTE. Should be very familiar with DTYPE records, imputation and other complex algorithms.
● Creates project-specific macros and formats.
● Prepares data to be sent to clients and as needed for other external transfers and data imports.
● Must be able to collaborate with US time zones to support internal team activities and sponsor meetings.
● Must be able to attend all study meetings.
In addition to the above job duties, SP II also:
● Assists manager and/or director to keep track project timelines and deliverables.
● Leads junior programmers in daily activities and performs on-the-job training to them.
● Communicates with clients about risks, issues, and potential delays.
Qualifications:
● Ability to communicate effectively in English, in both writing and verbal.
● Ability to learn quickly and pay attention to details.
● Ability to manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on time deliveries.
● Ability to work collaboratively, effectively, and productively in diverse organizational structures, and in interaction with dynamic clients.
● Ability to work independently takes ownership and strives for quality and efficiency.
● Ability to work positively in a continually changing environment.
● Solid/Advanced SAS skills and understanding of the concept of standardization in data, programming, and statistical reporting of trial results and its implication to drug development.
Requirements:
● Bachelor’s degree, but master’s degree or above, is preferred, in Biostatistics, Computer Science, Mathematics, Pharmaceutical science or relevant scientific fields and relevant industry experiences.
● Strong SAS programming language and good knowledge/experiences of clinical trial and drug development.
● At least 5 or more years of clinical programming or SAS programming.
● SAS Base Certified. Other certifications like SAS Advanced are preferred.
Benefits:
● Family health plan.
● Birthday day off.
● Continuous training through content platforms.
And more!
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