Senior Director, Clinical Biometrics & Analytics

Chiesi USA, Inc.; Parma; Hybrid; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Continuous training and development

Flexible working approach

Support for relocation

Tax assistance service for foreign colleagues

Job summary

A leading pharmaceutical company is seeking a strategic leader for Global Clinical Development in Parma, Italy. The role involves overseeing data management and statistical programming. The ideal candidate will have an advanced degree and a minimum of 10 years in management roles, as well as experience in clinical development. This position promotes innovation in clinical data strategies and offers a flexible working environment, focusing on the well-being and development of its employees.

Qualifications

• Minimum 10 years of experience in management or leadership roles in global biometrics.
• Deep knowledge of GCP, ICH, CDISC (SDTM, ADaM), and regulatory requirements.
• Familiarity with innovative data approaches considered a strong asset.
• Strong knowledge of GCP, ICH and regulatory requirements.
• Expertise with SAS, R and modern clinical data systems (EDC).
• Familiarity with adaptive designs and automation tools is a plus.

Responsibilities

• Define and execute the data and statistical vision in alignment with Global Clinical Development and R&D strategy.
• Oversee planning, conduct, and delivery of clinical data management and statistical analysis activities.
• Partner closely with Clinical Operations, Regulatory, Medical Affairs, and other key functions.
• Build and mentor high-performing teams and promote a collaborative culture.
• Collaborate with Regulatory, Medical Affairs, and Clinical Operations for trial design and submissions.

Skills

Strategic mindset

Leadership

Communication skills

Decision-making

Organizational skills

Education

Advanced degree (MSc or PhD) in Biostatistics, Mathematics, Life Sciences or related discipline

Tools

SAS

R

EDC systems

CDISC SDTM/ADaM

Job description

About Us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

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

• 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 and 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 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 flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.