Biogen · 9 hours ago
Principal Clinical RBQM Programmer
Research Triangle Park, NC
Full-time
Hybrid
Senior Level, Lead/Staff
$116K/yr - $155K/yr
5+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. The Principal Clinical RBQM Programmer is responsible for implementing and maintaining RBQM statistical monitoring solutions to support clinical trials, collaborating with various teams to ensure data integrity and compliance with regulatory standards.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
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
Qualification
Required
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
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
Preferred
Experience with Industry leading analytical tools is a plus
Master's degree preferred
Experience with data visualization tools and familiarity with GCP and ICH guidelines is highly desirable
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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