Statistical Programming and Data Management Specialist
Workplace: Mölndal, Sverige
Expires: December 6, 2025
Join Ribocure, an agile and innovation-driven biotech company, as a Statistical Programming and Data Management Specialist. In this role, you will ensure the integrity, compliance, and efficiency of clinical data processes and systems, combining data technology, statistical programming, and GxP IT to support clinical trials. You will manage GxP-compliant systems and data infrastructure, enable innovation including AI integration, and collaborate across departments to drive data quality and streamlined processes in a dynamic biotech environment.
Main requirements:
  • 3–5 years experience in clinical data management, statistical programming, or GxP IT
  • Hands-on experience with statistical programming (e.g., SAS, R) and CDISC standards (SDTM, ADaM)
  • Strong knowledge of clinical trial data flow and clinical development lifecycle
  • Experience with data warehousing and data architecture related to clinical trial data
  • Experience managing validated systems in GxP-compliant settings (CSV)
  • Familiarity with ICH E6, 21 CFR Part 11, GDPR and other relevant regulations
  • Proven ability to work cross-functionally, manage priorities, and meet deadlines
  • Excellent collaboration skills and proactive mindset
  • Curious, structured, and confident working independently and in teams
Responsibilities:
  • Establish and maintain clinical data repository for data handling and long-term storage
  • Maintain real-time trial data dashboard
  • Act as strategic partner across departments to align and integrate digital infrastructure
  • Collaborate with biostatisticians, data managers, and clinical teams
  • Generate statistical outputs including TLFs for monitoring boards and clinical reports
  • Conduct or oversee statistical programming and produce regulatory-ready datasets
  • Ensure data exports for internal and outsourced clinical trials
  • Produce data review listings and ad-hoc reports
  • Generate input for posters and publications
  • Manage eCRF set-up, maintenance and data management in non-investigational studies at Ribocure Clinic
  • Document clinical trial data flows and support data lifecycle management
  • Own and manage GxP-compliant IT systems and data repositories
  • Integrate AI and automation tools to optimize data quality and efficiency
  • Lead system and equipment validation and maintain GxP IT SOPs, policies and audit readiness
  • Develop and maintain SOPs and IT policies per CSV and guidelines
  • Lead implementation of new digital and AI-based tools for clinical development
  • Facilitate collaboration with cross-functional teams including Ribocure Clinic, Lab, Clin Pharm, biostatistics, medical team, QA
  • Provide technical input and programming support to resolve data issues
  • Shape efficient data flows and quality-focused processes
  • Serve as Ribocure’s Data Protection Officer (DPO)
Required hard skills:
  • Statistical programming with SAS and R
  • Knowledge of CDISC standards (SDTM, ADaM)
  • Clinical trial data flow and development lifecycle
  • Data warehousing and clinical data architecture
  • Experience in validation and management of GxP-compliant IT systems (CSV)
  • Familiarity with regulations such as ICH E6, 21 CFR Part 11, GDPR
Recommended hard skills:
  • Experience with Python
  • Data visualization using modern tools
  • Medical device data management and compliance
  • AI, automation and emerging data technologies in clinical development
Soft skills:
  • Structured and pragmatic approach
  • Collaborative teamwork and cross-functional cooperation
  • Can-do mindset and proactive attitude
  • Curiosity and confidence working independently and in a team
  • Ability to manage priorities and meet deadlines
Coding languages:
  • SAS
  • R
  • Python
Natural languages:
  • English (Proficient)
Cultural skills:
  • Agile and innovation-driven environment
  • Mission-focused with visible impact
  • Dynamic and fast-growing biotech company
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