Description
SUMMARY:Partners with clinical data management, statistical programmers, and biostatistics staff to develop dataset specifications, data review tools, datasets and reports on data from Phase I-IV clinical trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Develops and reviews dataset specifications following company and CDISC (SDTM and ADaM) standards, including production and interpretation of OpenCDISC reports.
* Develops programs and supports quality control and compliance checking of raw, SDTM, and analysis datasets following company conventions and guidelines, including documentation of quality control activities performed.
* Develops data review tools to assist with clinical data review.
* Updates raw, SDTM, and analysis datasets on Unix.
* Creates and/or reviews annotated CRFs, define.xml, define.pdf, and Reviewer's Guide.
* Must be able to program defensively, check results, and consistently produce accurate output.
* Independently verifies other programmers' results.
* Adheres to department standards and guidelines.
* Supports ad-hoc requests as needed.
* Works on multiple tasks at the same time and prioritizes tasks to meet business needs.
* Trouble-shoots moderately difficult technical and project issues.
* Assists team to ensure timelines for the study and/or project are met.
* Demonstrates flexibility and communicates effectively with outside departments and/or groups.
* Works well with study programming lead, other programmers, data managers, and statisticians.
* Meets timelines on a regular basis.
EDUCATION/EXPERIENCE/SKILLS:
Education:
* BS/BA degree in related discipline and 7 years of related experience; or,
* MS/MA degree in related discipline and 5 years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience:
* At least 5 years experience in clinical and/or statistical programming using SAS.
* UNIX, S-Plus, CDISC (SDTM & ADaM), and SAS/GRAPH/SG Procs experience desirable.
* Experience in Biotech/Pharmaceutical industry preferred.
* Experience following regulatory requirements (e.g., GCP, ICH)
* Oncology clinical research experience preferred.
* Experience using RECIST criteria preferred.
* Electronic Data Capture (EDC) experience working with raw data extracts preferred (esp. Oracle, InForm).
Knowledge/Skills/Abilities:
* Excellent SAS programming skills required, with proficiency in SAS/Base, SAS macros, and the Output Delivery System (ODS).
* Performs a variety of tasks with a wide degree of creativity and latitude.
* Has good general knowledge of other related disciplines.
* Ability to communicate verbally and in writing in a clear and timely manner.
* Ability to read, understand, and interpret study protocols, statistical analysis plans, and data review plans.
* Solid knowledge and understanding of lab data, reported, SI, and conventional units, normal ranges, conversion factors, CTCAE toxicity grading, and hematology differentials.
JOB COMPLEXITY:
* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
* Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
* Networks with key contacts outside own area of expertise
To find out more about Real please visit www.realstaffing.com