Biostatistics Director for Evidence Generation

Biostatistics Director for Evidence Generation

Daiichi Sankyo Europe

Multiple Locations, Europe

Purpose of the function

The position holder will be responsible for leading Biostatistical strategy and will be accountable for all the Biostatistical activities for Medical Affairs (MA), Health Economics and Outcome Research (HEOR) and Health Technology Assessment (HTA) for one Specialty Medicine compound.

The position holder will demonstrate leadership, strategic thinking and excellent communication skills for the interactions with internal and external stakeholders to optimize Statistical deliveries in time, quality, and budget for the compound under responsibility as well as statistical methods, processes, and standards.

The position holder will be responsible to coordinate and/or manage other Biostatisticians assigned to the same compound as well as interact and ensure alignment with data management and statistical programmers.

Roles and Responsibilities

Project Responsibility

• Accountable for all functional activities for one Compound. Acting as the functional expert within the assigned program, 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);
• Function as project lead and is accountable for all deliverables performed by Biostatisticians assigned to the same compound or from line function assigned to the project across the global/regional evidence generation activities;
• Functions as Statistics escalation point for all studies/activities within the assigned program;
• May lead critical studies from design to analysis execution and interpretation;
• Ensure timely, to budget and accurate completion of Statistical deliverables, including but not exclusive to the inputs for the development of study protocol (design, sample size, statistical analysis strategy), SAP or Payer Statistical Analysis Plan and 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;
• Ensure compliance with international regulations;
• Ensure inspections readiness as well as prepare and may participate in potential audits linked to assigned studies;
• Responsible for providing senior governance, direction, and execution of oversight of vendor delivery;
• Responsible for budget management activities across the area of responsibility.

Line Management

• May lead a team, including recruitment, coaching, mentoring and formal performance review and development;
• May lead a cross functional project team.

Operational Excellence and Innovation

• May sponsor, lead and/or participate in 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 Statistical team members as well as representing the department in cross-functional teams;
• Demonstrates leadership within Biostatistics by partnering with internal and external stakeholders to optimize Statistics technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).

Education & Experience

• Master’s degree or PhD (preferable) in statistics, mathematics or related fields;
• At least 10 years of experience as statistician (with at least three in Pharma) supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting;
• Experience in late phase projects 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;
• Extended knowledge and understanding of 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 explaining in simple terms complex concepts;
• Demonstrated entrepreneurship and leadership and proactive problem solving.

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