Associate Director, Statistical Programming

3 weeks ago


Atlanta, United States Daiichi Sankyo, Inc. Full time

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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


The purpose of this job is to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and R shiny app development to support clinical data analysis. Lead the R programming implementations. Represent programming in DS external collaborations on R technology and capabilities.
Responsibilities
- Lead/contribute to DS R programming system technology development:
Lead/contribute to the R programming system development. Act as R programming SME and functional representative of R systems and infrastructure to identify system and technology development needs and to define functional requirements. Provide technical guidance to the development. Lead and may approve UATs. Lead/contribute to resolutions of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties. Lead the trainings and implementations of R system and programming technology.
- Developing R package and Shiny apps:
Contribute to strategy of R programming innovation to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the development and validations of R package and/or shiny apps. Identify and build the use cases and process/resources to guide the implementations. Lead, advocate and nurture R programming innovation globally within DS. Represent the programming innovation outside of DS and establish the company reputations and images.
- Develop study specific shiny apps or execute shiny apps at study level. Publish shiny apps for study or against integrated database
- Representing cross-functional collaborations on R capabilities and systems:
Collaborate with RD non-BDM and non-RD R user group or developers. Collaborate with biostat innovation to enhance BDM overall R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (i.e., ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance



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 an accredited institution in a science or in a technical field such as computer science or mathematics required
- Master's Degree preferred


Experience Qualifications
- 10 or More Years Bachelor's degree with minimum 10 years (or Master's degree with minimum of 7 years) proven experience required
- 7 or More Years Previous experiences in R programming area, involved in R and/or Shiny app development and implementation. required
- Advanced working knowledge of all aspects of the R and SAS programming language used in clinical trials programming. required
- Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis required
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. required
- Having knowledge of all phases of drug development, including early and late phase clinical development and submission required
- Having solid background of applied statistics required
- Solid knowledge of new advanced statistical methods using SAS or R required
- Advanced knowledge in database structures and set-up required


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.


Estimated Salary: $20 to $28 per hour based on qualifications.



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