Ribocure Pharmaceuticals is a clinical stage biotech company specializing in oligonucleotide therapeutics. We are utilizing short tailor-made RNA segments to block the formation of certain proteins involved in diseases across multiple therapeutical areas.

About the job

As Ribocure’s Statistical Programmer, you will play a crucial role in the delivery of outputs from our clinical trials, but also in other various programming tasks. Since Ribocure is a small company, your responsibilities will span a wide range of tasks across several areas. This will give you the opportunity to work on diverse and meaningful projects in an intellectually stimulating, collaborative and fun environment.

The job will be office-based in our premises in the GoCo Health Innovation City, where we have a modern office, an in-vitro lab as well as our own Phase II clinical trial unit where we receive patients for participation in our clinical trials.

Responsibilities

• Produce full CDISC packages (SDTM and ADaM datasets, define.xml, annotated CRF, Study data/Analysis data reviewer’s guides etc.)
• Generate TLFs for clinical trial reports and data/safety monitoring boards
• Collaborate with biostatisticians, data managers and clinical teams to ensure data quality and accurate analyses
• Produce various data review listings and ad-hoc reports
• Review and approve CRO statistical programming deliverables
• Give input to and review e.g. Statistical Analysis Plans, Clinical Trial Reports
• Generate input to posters and publications
• Perform other tasks as necessary

Essential requirements

• Proficient in R programming
• Vast conceptual and practical programming experience related to CDISC standards and deliverables
• Proficiency in creation of full CDISC packages (ADTM, ADaM, Define-XML, Reviewers guides, aCRF etc.)
• Vast experience from TFL and ad-hoc report programming
• Thorough understanding of clinical trial protocols and the overall clinical development process
• Detailed understanding of the full biometrics field including clinical data management and biostatistics
• Understanding of functions supporting clinical development (Pharmacovigilance, QA, Medical Monitoring, Pharmacology, Regulatory Affairs, IT, Vendor Management, Supply Chain, etc.)
• Awareness of governing regulations and standards e.g. ICH Efficacy Guidelines, GDPR, 21 CFR Part 11, CDISC, Good Programming Practice
• Experience from clinical trial/program data submission to regulatory authorities
• Willingness to work across all company functions to explore and resolve any scientific or non-scientific questions where programming is necessary

Desirable requirements

• Experience of negotiating statistical programming components of CRO proposals
• Experience of supporting response to regulatory queries
• Python programming skills
• Experience of setting up data visualization tools (Spotfire, Power BI or Tableau)
• Experience of Clinical Data Repositories (structure, access management, automation etc.)
• Practical experience or willingness to expand into clinical data management and support the setup and validation of trials in EDC systems, data quality control, database lock support etc.

Personal attributes

• Analytical thinking with ability to understand complex problems and develop logical, data-driven solutions
• Attention to detail, ensuring accuracy and thoroughness in programming and data validation
• Adaptability and flexibility to work beyond boundaries across multiple company functions
• Self-motivated, with ability to take initiatives, prioritize and deliver without constant supervision
• Resilient, with ability to handle rapidly changing project requirements and set-backs with a positive attitude
• Curious, with a constant eagerness to learn and improve and stay abreast of evolving trends and methods

Our offer

We offer a competitive salary, a comprehensive benefits package and opportunities for growth and advancements. The career level will be adjusted based on the candidate's experience. We are an equal opportunity employer welcoming applicants from all backgrounds.

If you believe this job would be a good match, then apply as soon as possible. We will assess candidates on an ongoing basis.

Last application date: January 31st, 2025

Hiring Manager: Pontus Boman, Head of Data Science and IT

Location: GoCo Health Innovation City, Gothenburg/Mölndal, Sweden

This recruitment is quality assured by HR On Demand. No other agencies needed, please.