Director of Programming, Safety Lead

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 125 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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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 BDM activities on compound or cross-compound level safety signal detection. Represent BDM in cross-functional collaborations with safety team. Liaison with biostatistics function to drive signal detection analysis and programming deliverables. Lead the programming early safety integration and signal detection analysis. Lead central statistical monitoring programming supports for RBQM.

Responsibilities

• Leading BDM activities on compound or cross-compound level safety signal detection: Represent BDM in cross-functional collaborations with safety team. Work with safety team to identify signal detection needs and develop specifications for resolution. Work with programming technology team to develop macro or tools from the specifications. Liaison with biostatistics function to drive signal detection analysis and programming deliverables. Ensure signal detection BDM deliverables on time and with high quality.
• Lead central statistical programming supports for RBQM: Liaison with RBQM related functions to gather technical specifications to develop central statistical monitoring (CSM) Rshiny apps or tools. Work with programming technology team to develop Rshiny apps or tools from the specifications. Lead the CSM programming implementation for study level deliverables.
• Leading the programming early safety integration and signal detection analysis: Establish the programming safety team to enable programming for early safety integration and support safety signaling detection analysis. Build integrated safety datasets, and deliver outputs run against safety datasets.
• BDM safety 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 BDM safety team to set up goals/objectives and evaluate individual performances.
  
  
  

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)

• Bachelor's Degree in mathematics, statistics, or computer science preferred
• Master's Degree in mathematics, statistics or computer science preferred
  
  
  

Experience Qualifications

• 10 or More Years experience in pharmaceutical industry preferred
• Thorough understanding and proficiency of CDISC standards. Advanced knowledge of CDISC requirements for DTM and ADaM. preferred
• Thorough knowledge and experiences in integrated analysis on safety for submission and/or other purposes. preferred
• Experience in programming innovations beyond traditional SAS programming preferred
• Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred
• Working knowledge in R and/or Python preferred
• Strong project management experience and ability to manage and execute multiple projects and deadlines.
  
  
  

Travel

• Ability to travel up to 10%
  
  
  

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.