Full time

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Life changing therapies. Global impact. Our strategy includes building teams across our integral network to pioneer and shape the future of PCI.
Document Management and Control - Organize, scan, archive, and maintain R&D; department documentation. Ensure document traceability, version control, template management, and compliance with internal procedures and GMP requirements.
~Data Management and Reporting - Create, maintain, and update departmental databases and tracking tools using Smartsheet, Excel, and other systems. Compile data generated during trials and batches and prepare process charts, reports, and graphical trend analyses.
~Change Control Support - Coordinate and manage basic document-related change controls and support documentation updates in collaboration with project team members.
~Production Data Collection and Analysis - Obtain and compile primary data from manufacturing equipment in accordance with cGMP requirements and internal PCI procedures. Generate process monitoring charts and supporting documentation.
~Training Administration - Monitor training compliance within the R&D; department and support the creation, maintenance, and filing of training records.
~Compliance - Maintain knowledge of and comply with all company policies, internal procedures, quality standards, safety requirements, and applicable cGMP regulations.

Knowledge of current Good Manufacturing Practices (cGMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.
Works directly with R&D; management, scientists, technicians,



and project teams.
Works closely with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing, and Project Management departments.
Coordinates with internal stakeholders regarding documentation, training, materials, procurement activities, and change controls
Associate Degree, Vocational Training, or Bachelor's Degree
Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and database management tools such as Smartsheet.
Familiarity with cGMP documentation practices and document control systems is highly desirable.
Creative with the ability to work with minimal supervision and balance with independent thinking.
Join us and be part of building the bridge between life changing therapies and patients. Programmer (SAS & R) with German - Spain-based (remote/hybrid)

Full time
We are looking for a highly motivated HTA Programmer (Analyst/Consultant) to support health technology assessment (AMNOG) and market access activities in Germany. The role is ideally suited for biostatisticians or data scientists with a strong interest in applying clinical evidence to reimbursement and market access decision‑making. Contribute to the development of German AMNOG dossiers, with a focus on programming of statistical analyses for Module 4




Perform scientific assessment and analysis of clinical trial data, including analysis of efficacy, safety, patient‑relevant endpoints, and subgroup analyses
Perform meta‑analyses and indirect treatment comparisons and support interpretation of statistical outputs
Contribute to the automation and standardization of analysis workflows to ensure efficiency, consistency, and reproducibility
Collaborate closely with cross functional teams (Market Access, HEOR, Medical Affairs, EU‑HTA Team)
Ensure scientific quality, clarity, and consistency of generated outcomes
Master's degree or PhD in biostatistics, data science , or a related field
Initial experience in HTA, AMNOG, HEOR, or Market Access (industry, consultancy, or research institute preferred) and/or in clinical development
Solid understanding of clinical study designs, endpoints, and statistical principles
Familiarity with clinical study data and the corresponding industry standards (CDISC SDTM/ADaM)
Familiarity with the German AMNOG process , IQWiG methodology, or G‑BA procedures is an advantage
Ability to translate complex data into clear and structured output
~ Affinity for data and excellent analytical and conceptual skills
~ Strong background in statistics/data sciences/programming with a focus on process automation
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~2 years experience in advanced SAS programming , R programming skills are an advantage
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~2 years hands‑on clinical data analysis experience with CDISC SDTM/ADaM datasets
~ Solid understanding of core statistical methods used in clinical trials and HEOR

Structured, reliable, and quality‑driven working style
Fluent German and English** , written and spoke

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