Senior Director, Clinical Biometrics & Analytics

Chiesi Group; Parma; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a leader for the Global Clinical Development team. In this role, you will be responsible for the strategic direction and operational oversight of Data Management and Statistical Programming functions. Your focus will be on innovative methodologies, driving compliance, and fostering collaboration across teams. The ideal candidate has a strong background in biostatistics and over 10 years of experience in clinical development. This position offers flexible working options across Europe, including remote work.

Servizi

Continuous training and development

Flexible working approach

Relocation support

Tax assistance for foreign colleagues

Focus on work-life balance

Competenze

• Minimum 10 years of experience in leadership roles in global biometrics.
• Experience in early- and late-phase clinical development.
• Deep knowledge of GCP, ICH, CDISC standards.

Mansioni

• Define and execute the data and statistical vision.
• Oversee clinical data management and statistical analysis.
• Manage and develop high-performing teams.

Conoscenze

Leadership

Strategic planning

Communication

Collaboration

Decision-making

Formazione

Advanced degree (MSc or PhD) in relevant field

Strumenti

SAS

R

Descrizione del lavoro

Who we are looking for

Strategic leadership role within Global Clinical Development, responsible for overseeing Data Management, Biostatistics, and Statistical Programming functions. The position drives the vision, execution, and innovation of clinical data strategies across all phases of drug development, ensuring scientific rigor, operational efficiency, and regulatory compliance. Acts as responsible manager and high-functioning leader, accountable for building high-performing teams and fostering a culture of collaboration, accountability, and continuous improvement.

This is what you will do

You will be responsible for

Strategic Direction & Innovation

• Define and execute the data and statistical vision in alignment with Global Clinical Development and R&D strategy.
• Introduce and support new methodologies and technologies (e.g., innovative designs and approaches, AI‑based analytics, digital endpoints) to accelerate and optimize clinical drug development.
• Ensure data and evidence generation capabilities evolve with industry trends and internal needs.

Functional & Operational Oversight

• Oversee efficient planning, conduct, and effective delivery of clinical data management and statistical analysis activities.
• Ensure functional excellence across protocol development, CRF design, data standards, statistical analysis plans, programming, and reporting, and submission dossiers.
• Uphold outsourcing strategies and manage strategic relationships with CROs and technology vendors.

Leadership & People Management

• Provide line management and career development to functional leads and team members in Data Management, Biostatistics, and Statistical Programming.
• Build technical capabilities, foster talent development, and promote a high‑performance, collaborative and innovation‑oriented culture.
• Support organizational growth through strategic hiring and internal mentoring.

Cross‑Functional Collaboration

• Partner closely with Clinical Operations, Clinical Excellence, Regulatory, Medical Affairs, and other key functions to ensure alignment and seamless trial execution.
• Act as a strategic contributor in clinical study design, development plans and submission dossiers, ensuring statistical and data quality excellence, and supporting data democratization.

Represent data and statistical functions in internal governance bodies and external engagements, including with regulatory bodies, conferences, thought leaders and HTA bodies where required.

You will need to have

• Advanced degree (MSc or PhD) in Biostatistics, Mathematics, Life Sciences, or related discipline.
• Minimum 10 years of experience management or leadership roles in global biometrics.
• Experience in both early‑ and late‑phase clinical development, preferably in a pharmaceutical setting.
• Deep knowledge of GCP, ICH, CDISC (SDTM, ADaM), and regulatory requirements.
• Expertise in tools such as SAS, R, and modern clinical data systems (EDC).
• Familiarity with innovative data approaches (e.g., clinical evidence integration, adaptive designs, automation tools) considered a strong asset.

We would prefer for you to have

Strategic mindset with operational discipline.

Proven ability to lead change, build teams, and influence across functions and levels.

Strong communication, decision‑making, and organizational skills.

Commitment to quality, compliance, and continuous improvement.

Location

Flexible location within Europe, with the possibility of remote working.

What we offer

You would join a dynamic, fast‑growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well‑being.

We want our people to come to work happy every day, and we know how important it is to find the right work‑life balance in order to be able to give our best. That is why we offer a flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people‑care services.