About This Role
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.
What You’ll Do
- 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.
Who You Are
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.
Required Skills
- 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
Education Requirements/Preferred Skills
- 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.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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 encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
