Statistical Programming and Data Management Specialist
Hr On Demand Sweden AB / Datajobb / Mölndal
2025-06-19
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hela Sverige At Ribocure, we are pushing the boundaries of science and innovation. As an agile and innovation-driven biotech company, we combine rigorous science with data tools to create real impact for patients. Now we're looking for a Statistical Programming and Data Management Specialist to join our growing team.
As Statistical Programming and Data Management Specialist, you will play a key role in ensuring the integrity, compliance, and efficiency of clinical data processes and systems. This is a hands-on and cross-functional role that combines data technology, statistical programming and GxP IT ensuring robust data strategies across clinical trials. You will take ownership of GxP-compliant systems and data infrastructure supporting ongoing clinical development, ensuring they meet regulatory standards while also enabling innovation, including AI integration.
The ideal candidate is structured, collaborative, and pragmatic - someone who can get things done, focus on the essentials, and serve as a technical anchor in a dynamic and fast-growing biotech environment. You'll be part of a small, cross-functional team where your contributions are visible, valuable, and varied.
What You'll DoData Management & Programming Establish and maintain the clinical data repository for data handling and long-term data storage
Maintain real-time data dashboard for visualization of trials
Act as a strategic partner across departments, driving alignment and integration within our digital infrastructure
Collaborate with biostatisticians, data managers and clinical teams to ensure high quality data and streamlined data flows
Generate statistical outputs including TLFs for data/safety monitoring boards, clinical trial reports etc.
Conduct or oversee statistical programming activities, including the production of TFLs and regulatory-ready datasets
Ensure sufficient data exports for internal and outsourced clinical trials
Produce various data review listings and ad-hoc reports
Generate input to posters and publications
eCRF set-up, maintenance and data management activities in non-investigational studies at Ribocure Clinic
Document clinical trial data flows and support data management activities throughout the trial lifecycle
Own and manage our GxP-compliant IT systems and data repositories
Integrate AI and automation tools to optimize data quality and efficiency
GxP IT & Compliance Lead system and equipment validation and maintain GXP IT SOPs, policies, and audit readiness
Develop and maintain SOPs and IT policies in alignment with CSV requirements and relevant guidelines
Lead implementation and integration of new digital and AI-based tools for clinical development
Cross-Functional Support Facilitate collaboration by working closely with Ribocure Clinic, Ribocure Lab, Clin Pharm, biostatistics, medical team, trial teams, QA etc.
Provide technical input and programming support to resolve complex data-related questions
Help shape efficient data flows and quality-focused processes across trials and functions
Act as Ribocure's Data Protection Officer (DPO)
What You Bring 3-5 years of hands-on experience in clinical data management, statistical programming or GxP IT
Hands-on experience with statistical programming (e.g., SAS, R), including use of CDISC standards (SDTM, ADaM)
Strong knowledge of clinical trial data flow and clinical development lifecycle
Experience of data warehousing and data architecture related to clinical trial data
Experience managing validated systems in GxP-compliant settings (CSV)
Familiarity with relevant standards and regulations (ICH E6, 21 CFR Part 11, GDPR etc)
Proven ability to work cross-functionally, manage priorities, and meet deadlines
Excellent collaboration skills and a "can-do" mindset
Curious, structured, and confident when working both independently and as part of a team
Bonus points if you have experience in small biotech, are familiar with additional programming languages such as Python, and enjoy visualizing data using modern tools. Familiarity with medical device data management and compliance, as well as an interest in AI, automation, and emerging data technologies to enhance clinical development, are also a plus.
Why Join Us?We offer more than a job - we offer a mission. You'll be part of a tight-knit, friendly team working on real challenges with real potential. Your ideas matter. Your work matters. And your growth matters to us.
Ready to Apply? We encourage you to submit your CV and cover letter promptly, as applications will be reviewed on an ongoing basis. Final application deadline: August 15.
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2025-12-06
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Hr On Demand Sweden AB (org.nr 556743-5036)
Arbetsplats HR On Demand
Kontakt Rebeckha Magnusson
rebeckha.magnusson@ribocure.com +46 (0)73 635 88 49 Jobbnummer 9397466