US - Houston, Texas


Data Management Programmer

Pharm-Olam International, a multi-national Contract Research Organization has an opening for a Data Management Programmer in its Global Data Division. This is an in-house, full-time position based at our Houston or Princeton offices in the USA.

Primary Goal

To create, modify and maintain programs, primarily in SAS, to support the clinical data management department. This includes 'Manual' Data Quality Checks (DQC), Data Review listings, data extracts, Data mapping from none CDISC SDTM to SDTM, data mapping from SDTM to ADaM and importing external data files (EDF).

To help design data review specifications. Manage and manipulate multiple large (SAS) data sets, including defining data review datasets and variables, performing calculations and summarizations. Prepare specific data review deliverables, combining multiple data sets to create cohesive data review reports to meet project team and or client specifications.

Key Responsibilities & Critical Objectives:

  • Responsible for programming and quality deliverable to support data management deliverables.
  • Responsible for quality control reviews of generated output to verify accuracy prior to delivery to client and or project team.
  • Responsible programming (SAS) in order to generate tables and listings for study data on assigned projects.
  • Responsible for assisting in the development of programming procedures for the department.
  • Communicates with DPM and other team members regarding status and deadlines of programming tasks.
  • Provides input from a programming perspective in planning for database design and/or analysis.
  • Documents all programs and procedures to ensure an accurate historical record of work completed on assigned project to conform to 21 CFR Part 11 requirements.
  • Develop and maintain programming specification for 'Manual' Data Quality Checks (DQC), data review listings, data extracts, data mapping from none SDTM to SDTM, data mapping from SDTM to ADaM, importing external data files (EDF) and other Data Management deliverables
  • Act as a technical resource for programming development.
  • Develop and maintain project / department level standard routines (SAS/Macro) to increase project efficiency and department productivity.
  • As required, deliver programming and procedure training to other programmers and the DM team.
  • Develop and maintain "Ad-hoc" programming and ongoing support process.
  • Attend team meetings for assigned projects as appropriate.
  • Performing responsibilities in accordance to corporate quality standards and values.
  • Other duties as assigned.

Working Relationships:

  • Report to the Manager, Data Systems
  • Liaise routinely with Data Systems Team, Data Project Manager (DPM) and Statisticians
  • Collaborate with Project Research Secretaries and support services
  • Liaise with scientific / medical staff of Sponsors
  • Liaise with sub-contractors (if requested by Data Project Manager)

Education Requirements and Qualifications:

  • Bachelors degree in a related field
  • Minimum of 4 plus years of (SAS) programming experience, preferred within the CRO industry
  • Pharmaceutical/clinical research experience required
  • Experience in the maintaining and supporting of Data Management processes in a distributed client base within a regulated environment
  • Thorough understanding of GCPs, ICH Guidelines and CFR (thorough understanding of assigned protocols)
  • Good understanding of the clinical, data management and statistics processes including terms and practices of the field
  • Good understanding of System Life Cycle process and applicable GCP regulations pertaining to Computer Systems, in particular 21 CFR Part 11
  • Must be proficient with computer, MS Word, Excel and the Internet
  • Good analysis and problems solving skills
  • Excellent English verbal and written communication skills required
  • Good organizational and time management skills; must be able to establish priorities and able to multi-task
  • Good business acumen with customer focus in interacting with peers, sites and clients
  • Influencing skills including negotiation and teamwork


For Consideration:

Interested candidates should forward their CV along with salary expectations to hr-USA@pharm-olam.com or via fax to +832 202 0564.

POI offers a competitive salary and benefits package, and excellent opportunities for career development.

PRINCIPALS ONLY.

NO PHONE CALLS PLEASE.

THIS POSITION IS NOT ELIGIBLE FOR RELOCATION ASSISTANCE.

(Closing Date: October 30, 2008) If we do not receive your resume by midnight on the closing date, we do not consider this to be a bona-fide application. The company does not retain applications if there is no job opening.