Statistical Programmer I

The Statistical Programmer I, works with supervision to support various programming activities related to the analysis and reporting of clinical study data.

Key Accountabilities:

Statistical Programming for Assigned Projects:

• Deliver best value and high quality service.
• Check own work in an ongoing way to ensure first-time quality.
• Use efficient programming techniques to produce low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.

Training:

• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Develop knowledge of SAS and processes/procedures within other functional areas.

General:

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.

Skills:

• Excellent analytical skills.
• Strong programming skills and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Ability to learn new systems and function in an evolving technical environment.
• Attention to detail.
• Ability to successfully work as part of a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.

Knowledge and Experience:

• Competent in written and oral English.
• Great communication skills
• Experience in R and Git/Gitlab
• Experience in Open source tool development will be preferred
• Experience in clinical -preferred, not mandatory-

Education:

• Educated to degree level in a relevant discipline and/or equivalent work experience