Statistical Programming & Technology Lead (AD)

Statistical Programming & Technology Lead
Pharmaceutical | Milan, Italy | Permanent | Hybrid

We are supporting an established pharmaceutical organisation in Milan with the appointment of a Statistical Programming & Technology Lead to join its Biometrics & Data Sciences function.

This is a highly influential role with the opportunity to build and shape the Statistical Programming & Technology capability from the ground up.
The successful candidate will be responsible for establishing the team, defining how the programming function operates and creating the standards, governance, technology and processes required to support global clinical development.

Alongside traditional statistical programming leadership, there is a strong focus on technical advancement, AI, automation, data visualisation and modern statistical computing technologies. The organisation is looking for someone who understands where statistical programming is heading and can translate new technologies into practical, compliant solutions within a regulated pharmaceutical environment.

Please note: this position requires 4 days per week working from the Milan office, with 1 day available for remote working.

What You'll Be Doing
You will take ownership of building and developing the Statistical Programming & Technology function, including:

• Building the programming team from scratch, establishing the organisational structure and recruiting, developing and managing the team as the function grows.
• Defining how the Statistical Programming & Technology space should operate, including processes, responsibilities, standards and ways of working.
• Providing leadership across statistical programming activities supporting global clinical development and evidence-generation programmes.
• Ensuring the quality, consistency and regulatory compliance of programming outputs across studies and programmes.
• Overseeing delivery of SDTM, ADaM, TLFs, Define.xml and submission-ready datasets and outputs.
• Establishing robust programming standards, reusable code, metadata, QC processes and best practices.
• Creating appropriate governance around programming tools and technologies, including the assessment, selection, adoption and ongoing use of new platforms.
• Driving technical advancement across the function, particularly around AI, automation, data visualisation and modern analytics.
• Helping define the strategy and future use of SAS Viya, alongside SAS, R and Python, within the statistical programming environment.
• Identifying where AI-enabled tools and automation can improve programming efficiency, quality and scalability while maintaining appropriate governance and validation.
• Supporting the development, governance and continuous improvement of the Statistical Computing Environment (SCE).
• Managing and providing oversight of CRO and FSP programming partners to ensure high-quality, timely and compliant delivery.
• Working closely with Biostatistics, Data Management, Medical Affairs, Clinical Operations and IT to create an integrated approach to clinical data and analytics.
• Leading continuous improvement initiatives and identifying opportunities to modernise the wider Biometrics & Data Sciences environment.

• An MSc or PhD in Statistics, Biostatistics, Mathematics, Computer Science, Data Science or a related quantitative discipline.
• 12+ years' statistical programming experience within pharmaceutical, biotechnology and/or CRO organisations.
• Proven experience building, leading and developing statistical programming teams.
• Strong people-management skills, with the ability to recruit, mentor and develop technical professionals.
• Experience establishing programming processes, standards, governance and quality frameworks.
• Strong knowledge of SAS and statistical programming within clinical development.
• Excellent understanding of CDISC standards, including SDTM and ADaM.
• Strong knowledge of ICH guidelines, regulatory requirements and submission standards.
• Experience ensuring the quality and compliance of statistical programming outputs for clinical trials and regulatory submissions.
• Experience managing and providing oversight of external CRO and FSP partners.
• A strong understanding of emerging technologies within statistical programming, including AI, automation and data visualisation.
• Knowledge or experience of SAS Viya, including an understanding of its role as a modern cloud-enabled analytics platform supporting advanced analytics, programming, data management and AI capabilities.
• Experience with R and Python would be highly desirable.
• An interest in how AI-enabled programming tools and modern analytics can be adopted within a regulated clinical development environment.

• The team and organisational structure.
• Programming standards and ways of working.
• Quality and governance frameworks.
• Technology and tool adoption.
• SAS Viya and the future statistical computing environment.
• AI and automation strategy.
• Data visualisation and advanced analytics capabilities.
• CRO/FSP partnerships and external delivery models.

• For someone who enjoys the combination of people leadership, statistical programming and technical innovation, this is an opportunity to create a modern programming capability rather than simply step into an established structure.
  
  Interested?
  If you are an experienced Statistical Programming leader who has the technical knowledge and leadership capability to build a function from the ground up, we would be very interested in speaking with you.
  
   

Interested?
Reach out to Aimee directly at aimee@warmanobrien.com to learn more or apply confidentially.