Associate Director, Statistical Programming - R Implementation

About the role

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to “be an innovative global healthcare company contributing to the sustainable development of society,” we are shaping a healthier, more hopeful future for patients, their families, and society.

The purpose of this job is to provide statistical programming technical support related to R programming, R‑related systems and technology. Develop and drive R programming, package, and R Shiny app development. Lead the R programming implementations. Represent programming in DS external collaborations on R technology and capabilities.

Responsibilities

• Lead or contribute to DS R programming system technology development, including the R programming system itself.
• Act as R programming SME and functional representative of R systems and infrastructure to identify system and technology development needs and define functional requirements.
• Provide technical guidance to development teams.
• Lead and may approve user acceptance testing (UAT).
• Lead or contribute to resolution of BDM departmental (internal and external) R‑related analysis and programming technical issues.
• Lead trainings and implementations of R system and programming technology.
• Contribute to strategy of R programming innovation to support BDM analysis and reporting, such as R Shiny apps for data surveillance, visualization, modeling, simulations, and safety signal detection.
• Lead the development and validation of R packages and/or Shiny apps.
• Identify and build use cases and processes/resources to guide implementations.
• Lead, advocate, and nurture R programming innovation globally within DS.
• Represent programming innovation outside of DS and help establish the company’s reputation and image.
• Develop study‑specific Shiny apps or execute Shiny apps at the study level.
• Publish Shiny apps for studies or against integrated databases.
• Collaborate with RD non‑BDM and non‑RD R user groups or developers.
• Collaborate with biostatistical innovation to enhance BDM overall R capabilities and implementations.
• Collaborate with CSPV to support safety signaling detections and across‑compound safety reviews (e.g., ILD).
• Collaborate with Clinical Development and Clinical Sciences for effective data surveillance.

Qualifications

• Bachelor’s degree from an accredited institution in a science, computer science, mathematics, or a technical field (required); Master’s degree preferred.
• Minimum 10 years of experience with a Bachelor’s (or minimum 7 years with a Master’s) in a relevant field.
• 7 or more years of experience in R programming, including R and/or Shiny app development and implementation.
• Advanced working knowledge of both R and SAS programming languages used in clinical trials programming.
• Advanced working knowledge of CDISC SDTM and ADaM, with extensive implementation experience in clinical trials analysis.
• Advanced understanding of statistical concepts supporting analyses and reporting of clinical trials.
• Knowledge of all phases of drug development, including early and late‑phase clinical development and submission.
• Solid background in applied statistics.
• Solid knowledge of new advanced statistical methods using SAS or R.
• Advanced knowledge of database structures and set‑up.
• Ability to travel up to 10 % of the time.

Pay

Salary Range: USD $171,120.00 – USD $256,680.00