Clinical Data Programmer
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
- 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