Clinical Data Programmer

Position summary

The Clinical Data Programmer provides overall SAS programming support the the Data management team. 

The CDP is responsible for developing and validate SAS programs to produce high-quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM datasets.

In addition she/he is responsible for developing study specific reports based on design specifications provided by the Clinical Data Manager.

Key activities and responsibilities

  • Build SAS datasets from the clinical database with emphasis on standardization.
  • Utilize SDTM guidelines to build SDTM datasets. Provide input to company SDTM guidelines.
  • Provide input in CRF design for easy SDTM mapping.
  • Clear and proactive communication with Data management team to clarify requirements and specifications, update on assignment status and convey data irregularities.
  • Maintains open communication with Clinical Data Managers.
  • Demonstrate positive working relationship with colleagues by keeping them up to date about progress of programming.
  • Maintains detailed documentation which accurately reflects conducted programming.
  • Evaluates project request for programming support by considering factors such as efficiency, quality, data integrity, before committing to an action; seeks out existing knowledge prior to developing new methods. Reach out to head of Data Management as appropriate.
  • Continuously evaluates timelines in relation to work completed and communicates impact on milestones to colleagues/Head of Data Management and Project team if necessary.
  • Recommends alternative work processes to improve quality or speed of deliverables and responds to questions on Data Management process, timelines, and data quality.
  • Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency.
  • Prepares in advance for internal meetings, completes action items within required timeframe, and attends internal meetings regularly, providing input, and demonstrating respect for opinions of others.
  • Conducts post-mortem analysis after programming milestone to determine positive and negative factors affecting the project and provides information along with metrics to Head of Data Management.
  • As a key member of the Data Management department, take active part in defining processes, procedures related to operational effectiveness of the used Clinical Data Management Systems.
  • Manage database transfer process and database specifications in collaboration with outside vendors for the purpose of providing in-house data management and analysis

Competences, skills and qualification

Competences and skills

  • Experience with SAS
  • Basic knowledge of CDISC-SDTM data standardization specifications or willing to learn
  • Good cooperation skills with colleagues
  • Ability to proactively identify project threats and work out mitigation plans
  • Demonstrating pro-active and independent delivery of tasks
  • Proficiency with Microsoft Office (Excel, Word, PowerPoint, and Outlook)
  • Excellent verbal and written communication skills and English fluency
  • Ability to identify areas needing development

Qualification, experience

  • Bachelor’s degree in medical, scientific, biological, statistical, computer science, or related field
  • Three years of relevant clinical trial Data Management experience in the pharma/biotech industry
  • Experience in planning, setup, conduct and reporting of different work assignmentss
  • Practical expertise programming
  • Communication and reporting experience

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