Técnico De Contabilidad

Dentobucal Clínicas Dentales; Pontevedra; Híbrido; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

PCI Pharma Services is seeking a Programmer (SAS & R) with German language proficiency to support health technology assessment and market access activities from Spain. The role focuses on statistical programming, analysis of clinical data, and automation of analysis workflows in a remote/hybrid setup based in Madrid, Spain.

The ideal candidate holds a Master's or PhD in biostatistics or data science, has >2 years in SAS programming, and is fluent in German and English.

Formación

• Advanced degree in biostatistics, data science or related field.
• Experience with HTA, AMNOG, HEOR or market access preferred.
• Strong knowledge of clinical study designs and data integrity.

Responsabilidades

• Contribute to statistical analyses for German AMNOG dossiers (Module 4).
• Perform analysis of trial data including efficacy and safety endpoints.
• Conduct meta-analyses and indirect treatment comparisons; support interpretation of outputs.

Conocimientos

Analytical skills

Teamwork & communication

Structured & detail‑oriented

Educación

Master's degree or PhD in biostatistics or data science

Herramientas

SAS programming

R programming

CDISC SDTM/ADaM

Descripción del empleo

Leon, Spain

Full time

JR

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

**We are PCI.**

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main responsibilities

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
• 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.
• Documentation Issuance - Generate and issue forms, templates, labels, logbooks, and documentation associated with R&D trials, equipment runs, engineering batches, manufacturability studies, and pre-stability studies.
• 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.
• Protocol and Report Preparation - Prepare simple protocols, reports, and controlled documents using approved templates and departmental standards.
• 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.
• Personnel Administration - Support onboarding and offboarding activities for R&D personnel and maintain associated administrative records.
• Procurement and Shipment Coordination - Manage purchasing requests, monitor purchase orders, coordinate receipt of materials and samples, and organize R&D shipments, including samples and development materials.
• Continuous Improvement - Identify opportunities to improve documentation workflows, administrative processes, and departmental practices to enhance efficiency and compliance.
• Compliance - Maintain knowledge of and comply with all company policies, internal procedures, quality standards, safety requirements, and applicable cGMP regulations.

Work Experience and Skills Required

Essential

• Knowledge of current Good Manufacturing Practices (cGMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.
• Demonstrated ability to manage multiple administrative tasks simultaneously while maintaining a high level of accuracy and attention to detail.
• Strong organizational, communication, and interpersonal skills with the ability to interact effectively across multiple departments.

COMMUNICATIONS & CONTACTS:

• 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
• Ability to work independently and collaboratively within a multidisciplinary pharmaceutical development environment.

Qualifications:

Essential

• 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.
• Honesty, integrity, respect and courtesy with all colleagues.
• 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.
• Resilient through operational and organizational change.
• Ability to work in a dynamic, fast-paced work environment.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future ( Employment Opportunity (EEO) Statement:** PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Programmer (SAS & R) with German - Spain-based (remote/hybrid)

Madrid, Spain

Madrid, Spain

Full time

R

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. A substantial part of the role involves **statistical programming**.

Key Responsibilities:

• 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
• Monitor and interpret methodological developments from IQWiG, G BA, and relevant HTA bodies

Your Profile:

Education & Technical Background

• 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

Skills

• Strong **analytical skills** and attention to detail
• 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**
• >2 years experience in advanced **SAS programming** , R programming skills are an advantage
• >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

Personal Competencies

• Structured, reliable, and quality‑driven working style
• Strong teamwork and communication skills
• Fluent **German and English** , written and spoken **(this is an absolute must)**
• Strong strategic and critical thinking skills focus on quality, service, and solutions.
• Well‑organized, highly independent, highly motivated
• Strong customer orientation, a high level of responsibility and reliability
• High attention to detail, and audit‑ready mindset

Please submit your CV in English.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi‑talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled