Associate Statistical Monitor

The Position

As an Associate Statistical Monitor, you will play a key role in maintaining and operating the Statistical Monitoring function. Your responsibilities will include:

• Operating and maintaining the Statistical Monitoring function to detect unusual data patterns, systematic errors, and potential non-compliance or fraud across trials and projects.
• Collaborating with trial and project teams to plan and execute Statistical Monitoring activities.
• Analyzing clinical trial data to identify irregularities and communicating findings to relevant stakeholders, including trial teams and management.
• Contributing to the development of competencies in Statistical Monitoring by exploring new methods and tools and supporting training initiatives.
• Sharing knowledge and insights to improve the quality of clinical trial data and prevent future occurrences of low-quality data.
• Actively participating in meetings, training sessions, and continuous process improvement initiatives.

Qualifications

We are looking for a motivated individual with the following qualifications:

• A university degree in life sciences or engineering (e.g., B.Sc., MSc, MD) or equivalent.
• 0-2 years of experience in the pharmaceutical industry, preferably with exposure to clinical trial data exploration and visualization.
• A solid understanding of clinical research, GCP, and data flow. - Basic knowledge of statistical methods and experience with reporting or publishing clinical/scientific data.
• Proficiency in computer systems and IT, with exposure to SAS JMP programming.
• Strong analytical skills, a quality mindset, and the ability to work independently with statistical monitoring and IT tools.
• Experience working in a regulated industry and familiarity with GxP and drug development guidelines. - A team-oriented personality with cross-cultural awareness and flexibility. - A proactive approach to learning and adapting to new situations in a dynamic environment.