Purpose of the function

• The position holder will be responsible for leading Data and Statistical Sciences (DSS) strategy for Medical Affairs (MA), Health Economics and Outcome Research (HEOR) and Health Technology Assessment (HTA) for at least one compound by contributing to evidence generation plan, pricing authorities' interactions and scientific communication.
• The position holder will demonstrate leadership, strategic thinking and excellent communication skills for interactions with internal and external stakeholders.
• The position holder will be responsible for coordinating activities of statisticians / data-scientists assigned to the compound(s) under responsibility as well as data managers and statistical programmers.

Roles and Responsibilities

Project Responsibility

• Accountable for project leadership of Data and Statistical Sciences for at least one Compound.
• Acting as a liaison within the assigned program(s), ensuring that activities for Evidence Generation are scientifically sound and that the evidence generated meets requirements of internal (Medical Affairs and HEOR) as well as external stakeholders (KOLs, HTA and Regulatory or Pricing Authorities) together with other DSS functions.
• Function as project lead and is accountable for coordinating deliverables performed by Biostatisticians assigned to the same compound or from analytics function assigned to the project across the global / regional evidence generation activities.
• Lead a cross functional project team.
• Functions as escalation point for all studies/activities within the assigned program(s).
• Proactively identifies and manages risks for assigned program(s) and/or initiatives.
• Ensure timely, to budget and accurate completion of analytics deliverables, including guidance for proper interpretation of statistical results.
• Contribute to documents submitted to Regulatory or Pricing Authorities.
• May participate as subject matter expert in meeting or teleconferences with Health Authorities.
• Contribute to CRO selection from RFI (Request for Information) to contract agreement and to budget and resource management activities across the study/project under responsibility.

Operational Excellence and Innovation

• May sponsor, lead and/or participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.
• Maintains current knowledge of industry best practice in statistical methodology
• May function as Subject Matter Expert for Biostatistics, by providing guidance and support to team members as well as representing the department in cross-functional teams
• Demonstrates leadership within Data and Statistical Sciences by partnering with internal and external stakeholders to optimize analytical technology, processes, and standards (improving quality, decreasing cycle times, and reducing costs).

Education & Experience

Education

• Master’s degree or PhD (preferable) in statistics, mathematics or related fields.

Experience

• At least 10 years Biostatistics or Data-Sciences experience in Pharmaceutical industry, medical device, or similar environment (e.g. CRO) of which at least 3 in Pharma.  
• Experience in oncology Therapeutic Area and in late phase projects. Experience in Evidence Generation space is an advantage.

Skills and additional Requirements

• Extended and up-to-date knowledge of statistical methods related to clinical studies and to HEOR/HTA applications, and insights into data science applications in the industry across product life cycle.
• Extended knowledge and understanding of key pharmaceutical industry best practices as well as the principles, concepts, methods, and standards of Clinical Research 
• Demonstrated expertise in study design, conduct and execution
• Excellent English language skills
• Excellent communication skills, both oral and written, in particular in the area of active listening and influencing
• Good negotiation and project management skills
• Demonstrated entrepreneurship and leadership and proactive problem solving