Director, Evidence Generation, Statistical Innovation (m/f/x)

Director, Evidence Generation, Statistical Innovation (m/f/x)

Date: 8 Oct 2024

Location: All Europe, Europe, 81379

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our EU regional headquarters in Munich or our affiliates in Europe (remotely also possible), we are seeking highly qualified candidates to fill the position:

The Position:

The Director, Evidence Generation, Statistical Innovation will be focused on enhancing statistical methodology of Biostatistics for Medical Affairs (MA), Health Economics and Outcome Research (HEOR) and Health Technology Assessment (HTA) activities.

• The incumbent will be responsible to drive statistical innovation and develop efficient study design and analysis as well as providing statistical expertise by collaborating and supporting EG (Evidence Generation) Biostatistics team in their project/study activities. This position collaborates with statistical teams, other functions, external experts and contract research organizations (CROs) in developing and implementing innovative methods in clinical studies.
• Responsibilities include planning, driving and contributing to biostatistics methodology initiatives; conducting statistical research; collaborating with statisticians to assess and implement complex and innovative study designs and ad-hoc analyses. The position holder will be responsible to provide training to statisticians and non-statistician colleagues; coaching and mentoring statisticians to help enhance their technical skills; and develop partnership with academic centers and oversee internship programs.
• This role will demonstrate statistical leadership, strategic thinking and excellent communication skills for the interactions with internal and external stakeholders.
• This position works under minimal supervision to conduct his/her activities and to solve complex project problems.

Evidence Generation Department Innovation: Identify, lead/contribute and drive EG biostatistics methodological initiatives and promote best practices. Lead strategic assessment of key innovation trends in the industry and drive their introduction in EG department by means of clear and simple communication as well by influencing the other EG leaders. Leads global functional and cross-functional innovation initiatives by coordinating the work of an assigned team of experts. Identifies training needs for the EG biostatistical department and provides statistical training to statisticians and non-statistician colleagues.

Develop and implement statistical methodology: Propose and develop statistical methodology in study design, modelling and ad-hoc analyses for internal teams and help team resolve complex problems and make better decisions for compound success optimization. Work with statisticians to assist with innovative study design, simulation, execution as well as to ensures clear and scientifically sound interpretation of analyses results by ensuring that the deliverable maximize the evidence generation to meet strategic goals and requirements of internal (Medical Affairs and HEOR) as well as external stakeholders (KOLs, HTA and pricing agencies). Develop programming codes and tools to facilitate the implementation of complex methods. Support the authoring of complex sections of clinical study documentations (e.g. Protocol, SAPs, pricing authorities and responses). Collaborate effectively by means of clear and effective communication with cross functional leaders to develop optimal statistical deliverables. Interpreting and presenting analysis results in a clear, concise, complete and transparent manner.

Statistical Methodology: Keep abreast of new developments in statistics, drug development and regulatory guidance. Lead and conduct methodological research and present and/or publish research findings. Keep himself/herself abreast on statistical methodological, regulatory or pricing topics. Identifies and develop partnership with Key Academic Statistical Institutions as well as manage relationship with Key Academic Statistical Leaders as well as define and implement external trainings tailored to EG Statistical strategic needs. Lead development of internship programs in alignment with department innovation strategy, including selection and supervision of individual internship trainees.

Vendor management: Review CRO/vendor proposal and budget where applicable. Establishes procedures through regular interaction, setting expectation on deliverables and timelines, and ensuring deliverables are accurate and delivered according to the timelines.

Qualifications:

Education Qualifications

• PhD in statistics or mathematics with a minimum of 10 years of methodological research experience in the pharmaceutical industry, regulatory agencies or academia required.

Experience Qualifications

• 10+ years of pharmaceutical industry experience, preferably in Evidence Generation.
• Demonstrated, proven knowledge of innovative statistical designs and analysis methods for drug development.
• Expertise in statistical methodological research in clinical trials.
• Must have extensive experience in Oncology.
• Must have experience in late phase projects.
• Must have solid understanding of ICH guidelines and requirements from global regulatory and pricing agencies.
• Must have demonstrated proficiency in R/R-Shiny or SAS programming.