DIS Programmer II Job in San Francisco, California US
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. In a highly fragmented industry, we are one of a small group of organizations with the capability and expertise to conduct clinical trials and development projects on either a local or global basis. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated "full service" solution.
Role Responsibility
This position is responsible for the annotation of case report forms (CRFs), creation of specifications, programming and validation of data sets and listings.
Additional responsibilities include:
- Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data.
- Review CRF annotations produced by other DIS programmers.
- Create CRT data set specifications per CDISC or sponsor specified requirements.
- Review CRT data set specifications produced by other DIS programmers.
- Program CRT data sets per specification.
- Validate data sets per the formal, documented QC process.
- Create and maintain supporting documentation.
- Receive, import and verify structure of external data.
- Program sponsor defined data review listings.
- Assist with training and/or mentoring of junior level DIS programmers.
- Liaise with Data Management and Biostatistics on database specifications, timelines and quality requirements.
- Liaise with sponsor as assigned.
- Demonstrable expertise with CDISC CDASH, SDTM, CRT-DDS, ADaM, and controlled terminology.
- Implementation of standard clinical data solution best practices from CRF design through data analysis and reporting.
Experience Qualification:
- B.S. or local equivalent in Computer Science, Mathematics, Life Science.
- A minimum of 5 years of relevant clinical research experience with 3 years specifically in the pharmaceutical industry.
- Demonstrated ability to produce CDISC SDTM, CRT-DDS (define.xml), and controlled terminology complaint structures.
- Experience with statistical programming; analysis data sets, tables, listings and graphs.
- Strong organizational, planning and problem solving skills.
- Strong oral and written communication skills.
- Strong interpersonal skills; team player.
Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive compensation and an exceptional benefits package that includes: Medical, Dental, and Vision Insurance, Flexible Spending Accounts, Short Term and Long Term Disability, Life and ADD Insurance, 401K Plan with matching contributions, a generous program of Vacation, Holidays and Personal Time Off and more.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.