Global Head, Statistics Oncology HEOR/HTA

Join a Legacy of Innovation – 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.

Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

The is a Director-level position.

JOB SUMMARY

•Be accountable for all Statistics activities conducted for a specific therapeutic area and/or customer (Health Economics and Outcome Research (HEOR) / Health Technology Assessment (HTA) or Medical Affairs), at Global, Regional and local levels, by Data and Statistical Sciences for Evidence Generation (DSS-EG), in collaboration with the Global Head of DSS-EG and global partners and stakeholders. The accountability will include the definition and execution of the vision, direction and strategy of the Statistics team within the area of responsibility as well as the development and execution in time, in quality and in budget of each statistical activities conducted, based on both primary and secondary (RWD) data, under the business lead of Global, Regional and local Business Partner.

•Ensure the execution of departmental activities in compliance with legal and pricing and/or regulatory authority requirements in each global region, as well as manage Statistics activities under responsibilities in front of internal and external audits and inspections.

•Be responsible for the performance of the global department and for the management and development of the team members as well as mentors or acts as functional manager of staff residing in other offices as needed.

•Collaborates with our business partners to recommend and implement a Data Strategy within the area of responsibility by capitalizing both primary and secondary data sources. Ensure solid networking and partnership with relevant internal and external stakeholders to leverage capabilities within the area of responsibility, drive operational excellence and foster innovation.

•The position will have extensive experience in the area of Statistics under responsibility, including leadership and line management, excellent interpersonal skills, experience in Medical Affairs or HTA /Pricing and Reimbursement activities, advanced knowledge of relevant statistical methodology (including in RWE, Patient Reported Outcomes and/or Observational research) and of industry standards as well as proficiency in project management and vendor partnership skills.

RESPONSIBILITIES
Business Leadership and Strategy

• Leads the strategy of the Statistics within the area of responsibility, in alignment with Global Head of DSS-EG as well as with global partners and stakeholders. Within the scope of responsibility, reviews and provides strategic input to portfolio under responsibility throughout product life cycle, and briefs senior management as needed. Ensures appropriate and proactive networking with key stakeholders, understands incoming business needs, may represent the function in cross-functional teams, and implement Global DSS vision and strategy in the organization.
• Defines and implements sourcing strategy for the activities under responsibilities, including the level of outsourcing and/or insourcing, in alignment with Global Head of DSS-EG.
• Accountable for implementing appropriate statistical methodologies and ensuring the optimal usage of advanced analytical approaches in the area of responsibility. Monitors and enforces compliance with policies, standards, standard procedures and processes as well as is responsible for regulatory audits and inspections in the area of responsibility.

Portfolio lead for Data and Statistical Sciences for HEOR/HTA Evidence Generation.

• Is responsible for development, conduct and execution of all Statistical activities in the perimeter, based on both primary and secondary (RWD) data, in time, in quality, in budget as well as in alignment with Global, Regional and Local Business Partner strategies through collaboration with internal and external stakeholders. Statistics activities include inputs for the development of primary data collection study protocols and secondary database study protocols (statistical design and analysis strategy), Statistical Analysis Plans (including for secondary usage of data), analyses execution supervision and guidance for proper interpretation of statistical results.

Team Leadership & Management

• Proactively identifies and manages risks at the functional level and/or for assigned programs, and/or initiatives. Functions as Statistics escalation point for all studies and projects under responsibility. Is accountable for the effectiveness, quality and compliance of all study and project documents in the area of responsibility.
• for recruiting, retaining, coaching, developing (both in technical and soft skills), and managing individual contributors and potential line Managers within his/her department. Is responsible for the performance of the global department. Identify staff training needs and ensure implementation of team development and departmental compliance training. Ensure efficient resources and talents management across regions. Mentor or act as functional manager of staff residing in other offices as needed.

Sourcing and Vendor oversight

• Final accountability for all the Vendors providing statistics services for projects under responsibility. Responsible for managing high-level governance, negotiations and partnerships with vendors. Is accountable for budget, resources and timelines with external vendors including contract research organizations (CROs) for multiple projects across the department and ensures timely delivery of high-quality deliverables at reasonable cost.

Operational Excellence and Innovation

• Leads the development and implementation of global vision and strategy to leverage innovation and operational excellence in Statistics for his/her team, grounded in current and emerging best practices and trends. Identifies opportunities and leverages network with internal / external stakeholders to lead, contribute to, and/or develop Statistics processes, standards and standard procedures to ensure compliance with legal and international guidelines and good practices across the global regions, while fostering the development of future success of the organization. Drives Statistics Innovation activities, in collaboration with DSS-EG Statistical Innovation, as well as makes recommendations for global/regional implementation. Leads and/or participates in Global functional and/or multi-functional / multidisciplinary teams and initiatives to enhance harmonization and efficiency across studies and projects under responsibility. Leverages Statistical expertise related to the assigned scope to promote best practices across the Drug Development lifecycle. Any other duties deemed pertinent to the needs of the business.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

• Master's Degree MSc in Biostatistics in Statistics, Mathematics or related field is required.
• A PhD preferred.
   

Basic Qualifications

• Must have 10+ years of professional experience in statistics within pharmaceutical industry, medical device, or similar environment (e.g. CRO) of which at least 5 years in Pharma and 3 years in evidence generation space.
• A Minimum 5 years of line management and leadership experience
• Experience in Oncology in conducting clinical programs and studies, including experience in late phase projects.
• Extended and up-to-date knowledge of statistical methods and statistics applications in the industry across product life cycle, in particular in Observational Research, RWE and Patient Reported Outcomes.
• Demonstrated expertise and experience in HTA and Pricing and Reimbursement activities, including the use of RWD, with significant experience with payer, as well as experience in the creation, management, and execution of processes and guidance documents.
• Extensive and significant knowledge of key pharmaceutical industry best practices as well as legislative, regulatory and industry artifacts/frameworks.
• Must have excellent communication skills in particular the area of active listening, coaching and influencing, both oral and written.
• Demonstrated strong leadership, strategic thinking and excellent collaboration skills along with a proficient entrepreneurial mindset.
• Advanced project management skills with the ability to manage multiple projects and prioritize tasks effectively, alongside demonstrated experience in continuous improvement and change management.
• Must have experience in CRO management at governance level.

Travel Ability

• Must have the ability to travel both domestic and international up to 10% to 15%

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.