Associate Director, Statistical Programming - R Implementation

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 171,000 - 257,000; Full time

Job summary

Daiichi Sankyo US seeks a senior Statistical Programmer to provide expert support for R programming, develop R packages and Shiny apps, and lead R programming implementations across studies.

You will collaborate with cross-functional teams, serve as R SME, guide development, and contribute to data surveillance and safety signaling with advanced statistics and CDISC SDTM/ADaM knowledge.

Qualifications

• Bachelor's Degree in a science or technical field such as computer science or mathematics required; Master's Degree preferred.
• 10+ years of experience with R programming and Shiny app development in clinical trials.
• Advanced working knowledge of R and SAS in clinical trials programming.
• CDISC SDTM and ADaM implementation experience in clinical trials analysis.
• Strong understanding of statistical concepts for analyses and reporting in clinical trials.
• Knowledge of all phases of drug development and applied statistics.
• Solid knowledge of new advanced statistical methods using SAS or R.
• Advanced database knowledge and setup.

Responsibilities

• Lead and contribute to DS R programming system development and strategy for R shiny apps.
• Provide technical guidance and act as R programming SME for internal/external collaborations.
• Lead UATs and resolve R programming issues across projects.
• Develop and validate R packages and shiny apps and publish study-specific apps.
• Collaborate with cross-functional teams to enable data surveillance and safety signaling.

Skills

R programming

Shiny app dev

CDISC SDTM/ADaM

SAS programming

Statistics concepts

Clinical trials

Drug development

Data surveillance

Education

Bachelor's degree in science/tech

Tools

SAS

Job description

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.

Job 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. 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

Education Qualifications

• 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 Requirements

Ability to travel up to 10% of the time.

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.

Salary Range

USD$171,120.00 - USD$256,680.00