Clinical Programmer

Confidential Company  •  West Milford, NJ

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/03/17 by Peter Chen
Confidential Company
West Milford, NJ
5 - 7 years experience
Salary depends on experience
Posted on 08/03/17 Peter Chen

Skills/Knowledge Required:

  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years’ experience
  • Advanced knowledge of clinical database design is a must (RAVE, InForm, Oracle Clinical)
  • Demonstrated proficiency in creating standard operational metadata, and CDASH compliant CRFs

In-depth understanding of CDASH and SDTM requirements

  • Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
  • Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
  • Knowledge of SAS programming

Responsibilities will include, but are not limited to:

  • Develop, program, test and maintain clinical trialdatabases and data entry screens using Oracle Clinical, Medidata Rave and InForm in accordance with Client standards.
  • Develop standard CRF metadata per Client standards; contribute to the creation of CDASH compliant CRFs.
  • Review computer validation/edit checks for in-house and outsourced studies.
  • Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS.
  • Develop, program, test and maintain data review listings in Oracle Clinical, InForm, JReview and/or SAS for data review purposes.
  • Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and Client standards.
  • Participate in and lead team meetings when appropriate.
  • Act as primary CRO contact as needed to ensure that Client standards are implemented in all studies.
  • Provide technical expertise and support to data management and study teams.
  • Control access to database and perform snapshots, database lock and freeze activities in accordance with Client SOPs.
  • Make data, including interim data, available to company personnel and regulatory agencies when required.
  • Perform post processing of data extracts in accordance with Client standards to be delivered to Biostatistics.
  • Routinely interface with cross-functional team members.
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