Director, Statistical Programming (Technology & Innovation)

Join a Legacy of Innovation 110 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 15,000 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.

Summary:

Provide strategic leadership for statistical programming activity related to macro/utilities, system and technology. Develop and drive programming innovations beyond the traditional programming knowledge. Lead the programming early integration and safety signal detection supports. Represent programming in cross-functional collaborations on technology and systems

Responsibilities

• Leading BDM programming system technology development: Lead programming macro and utility development. Act as programming SME and functional representative of BDM systems and infrastructure to identify system and technology development needs and to define functional requirements. Provide technical guidance to development. Lead and approve UATs. Lead resolutions of BDM departmental (internal and external) analysis and programming technical issues and difficulties. Lead the trainings and implementations of BDM system and programming technology.

• Developing and driving programming innovations: Define strategy of programming innovation beyond the traditional programming, such as machine learning and AI, broader spectrum of data sciences and biometric, R and Python beyond just SAS. Identify and build the use cases and process/resources to guide the implementations. Lead, advocate and nurture programming innovation globally within DS. Represent the programming innovation outside of DS, and establish the company reputations and images.
• Leading the programming safety signal detection supports: Establish the programming safety team to Enable programming for safety signaling detection. Build integrated safety datasets. Develop effective solutions or tools to support safety data reviews
• Representing cross-functional collaborations on technology and systems: BDM system committee programming representative. Collaborate with RDEx and IT for BDM programming system development and maintenance. Collaborate with biostat innovation to enhance entire statistical innovation and its implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (i.e., ILD). Collaborate with DM Data Operation to manage CDR&SCE and SMaRT view.
• Programming Technology Team Management: Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for individuals. People manager of programming technology team to set up goals/objectives and evaluate individual performances.

Education Qualifications (from an accredited college or university)

• Bachelor's Degree an accredited institution in Mathematics, Statistics, or Computer Science preferred
• Master's Degree in Mathematics, Statistics, or Computer Science preferred

Experience Qualifications

• 10 or More Years experience (Bachelor 12 or More Years) in pharmaceutical industry
• Thorough understanding and proficiency of CDISC.
• Advanced knowledge of CDISC requirements for SDTM and ADaM.
• Worked and played major role in electronic NDA and/or BLA submission via eCTD
• Working knowledge in R and Python
• Strong project and line management experience and ability to manage and execute multiple projects and deadlines.

Competencies:

• Proven SAS programming technical skills, and therapeutical area programming knowledge and skills
• Strong organizational skills, critical thinking, problem-solving abilities, time management skills and initiative development abilities
• Flexibility and ability to work on several tasks simultaneously. Leadership skill to develop compound from programming perspective. Must be able to make decision and lead a programming team to support projects.
• Strong stakeholder management skills and ability to effectively present programming function in a clinical team setting
• Ability to work as line manager and conduct performance assessment
• Superior English writing and oral communication

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.