Principal Clinical RBQM Programmer

Overview

The Principal Clinical RBQM Programmer is responsible for implementing and maintaining RBQM statistical monitoring solutions to support Risk-Based Quality Management (RBQM) strategies in clinical trials. This role involves configuring RBQM platforms, interpreting outputs, and collaborating with Data Management and Clinical Operations teams to ensure data integrity and compliance with regulatory standards. The position also supports integration of RBQM system with other clinical systems and contributes to continuous improvement initiatives for data quality oversight.

• Configure and maintain RBQM platform for assigned clinical studies (including Key Risk Indicators, Quality Tolerance Limits & Data Quality Analysis).
• Execute statistical monitoring algorithms and interpret Key Risk Indicators (KRIs) and Central Statistical Monitoring (CSM) outputs.
• Collaborate with Data Managers and Clinical Operations to define RBQM strategies and implement RBQM workflows.
• Perform data integration tasks between RBQM Platform and EDC systems, ensuring accurate and timely data flow.
• Build dashboards, visualizations, and data insights using analytics and visualization frameworks.
• Assist in integration activities with CTMS, EDC Connector, and other platforms.
• Generate dashboards, reports, and visualizations to communicate risk signals and data quality trends.
• Be trained to support industry-leading clinical study analytics software for developing dashboards and outputs that enhance the clinical portfolio.
• Participate in user acceptance testing (UAT) and provide technical support for RBQM Study setup related activities.
• Contribute to SOP development and process optimization for RBQM and statistical monitoring.

Driven and proactive, with a passion for learning. Able to quickly learn and adapt new tools, technologies, and complex data systems. Strong problem-solving skills and a collaborative mindset.

• 5+ years of experience in clinical data analytics or statistical programming within the pharmaceutical or biotechnology industry.
• Hands-on experience with CluePoints platform or equivalent RBQM tools.
• Proficiency in SQL, SAS, R, and Python for data processing and statistical analysis.
• Experience with industry-leading analytical tools is a plus.
• Strong understanding of clinical trial processes, data standards (CDISC), and regulatory requirements.
• Excellent problem-solving skills and ability to interpret complex statistical outputs.
• Effective communication and collaboration skills across cross-functional teams.
• Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem-solving ability, ability to develop trust, shared goals and values.
• Must have excellent oral and written communication / presentation / negotiation skills.
• Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner.
• Ability to handle multiple (changing) priorities under tight timelines.

• Bachelor’s degree required in Computer Science, Statistics, Life Sciences, or related field. Master’s degree preferred.
• Experience with data visualization tools and familiarity with GCP and ICH guidelines is highly desirable.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team…