PpSelect how often (in days) to receive an alert: /p h3Senior Director, Clinical Biometrics Analytics /h3 pDepartment: Global Clinical Development /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pBased 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: bDiscover more here /b /p pWe are proud to be the largest global pharmaceutical group to be awarded bB Corp Certification /b, a recognition of bhigh social and environmental standards /b. We are a breliable /b company that adopts and promotes a btransparent and ethical behavior /b at all levels. /p pWe believe that the success of bChiesi is built and shaped by our people and our strong set of shared Values and Behaviors /b. 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. /p pIn fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. /p pbChiesi Research Development /b /p pOur RD 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, RD 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). /p pbWho we are looking for /b /p h3bThis is what you will do /b /h3 pStrategic 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. /p h3bYou will be responsible for /b /h3 pbStrategic Direction Innovation /b /p ul liDefine and execute the data and statistical vision in alignment with Global Clinical Development and RD strategy. /li liIntroduce and support new methodologies and technologies (e.g., innovative designs and approaches, AI-based analytics, digital endpoints) to accelerate and optimize clinical drug development /li liEnsure data and evidence generation capabilities evolve with industry trends and internal needs. /li /ul pbFunctional Operational Oversight /b /p ul liOversee efficient planning, conduct, and effective delivery of clinical data management and statistical analysis activities. /li liEnsure functional excellence across protocol development, CRF design, data standards, statistical analysis plans, programming, and reporting, and submission dossiers. /li liUphold outsourcing strategies and manage strategic relationships with CROs and technology vendors. /li /ul pbLeadership People Management /b /p ul liProvide line management and career development to functional leads and team members in Data Management, Biostatistics, and Statistical Programming. /li liBuild technical capabilities, foster talent development, and promote a high-performance, collaborative and innovation-oriented culture. /li liSupport organizational growth through strategic hiring and internal mentoring. /li /ul pbCross-Functional Collaboration /b /p ul liPartner closely with Clinical Operations, Clinical Excellence, Regulatory, Medical Affairs, and other key functions to ensure alignment and seamless trial execution. /li liAct as a strategic contributor in clinical study design, development plans and submission dossiers, ensuring statistical and data quality excellence, and supporting data democratization. /li /ul pRepresent data and statistical functions in internal governance bodies and external engagements, including with regulatory bodies, conferences, thought leaders and HTA bodies where required /p h3bYou will need to have /b /h3 pAdvanced degree (MSc or PhD) in Biostatistics, Mathematics, Life Sciences, or related discipline. /p pMinimum 10 years of experience management or leadership roles in global biometrics. /p pExperience in both early- and late-phase clinical development, preferably in pharmaceutical setting. /p pDeep knowledge of GCP, ICH, CDISC (SDTM, ADaM), and regulatory requirements. /p pExpertise in tools such as SAS, R, and modern clinical data systems (EDC). /p pFamiliarity with innovative data approaches (e.g., clinical evidence integration, adaptive designs, automation tools) considered a strong asset. /p h3bWe would prefer for you to have /b /h3 pStrategic mindset with operational discipline. /p pProven ability to lead change, build teams, and influence across functions and levels. /p pStrong communication, decision-making, and organizational skills. /p pCommitment to quality, compliance, and continuous improvement. /p h3bLocation /b /h3 pFlexible location within Europe, with the possibility of remote working /p pbWhat we offer /b /p pYou would join a dynamic, fast-growing, challenging and friendly environment.br/In Chiesi we firmly believe thatb our people are our most valuable asset /b, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular battention to the quality of our working environment and to collective well-being. /bbr/bWe want our people to come to work happy every day /b, and we know how important it is to find the right bwork-life balance /b 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. /p /p #J-18808-Ljbffr