Senior Manager, Statistical Programming - R Implementation

Daiichi Sankyo Europe

France or Germany

The Position

Please note that this position is primarily based in France, with Germany as an alternative location. The purpose of this position is to provide statistical programming and technical support related to R programming and R-related systems and technologies. The position develops and drives R programming, package development, and R Shiny app development. It also leads R programming implementations and represents programming in DS external collaborations regarding R technology and capabilities.

Roles and Responsibilities

Lead/Contribute to DS R Programming System and Technology Development:
- Lead/contribute to R programming system development
- Act as an R programming SME and functional representative for R systems and infrastructure to identify system and technology development needs and define functional requirements
- Provide technical guidance for development
- Lead and, where applicable, approve user acceptance testing (UAT)
- Lead/contribute to the resolution of BDM departmental (internal and external) R-related analysis and programming technical issues and challenges
- Lead training and the implementation of R systems and programming technologies
Develop R Packages and Shiny Apps:
- Contribute to the R programming innovation strategy to support BDM analysis and reporting, such as R Shiny apps for data surveillance, visualization, modeling and simulation, and safety signal detection
- Lead the development and validation of R packages and/or Shiny apps
- Identify and build use cases, processes, and resources to guide implementation
- Lead, advocate for, and nurture R programming innovation globally within DS
Represent programming innovation outside 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 individual studies or integrated databases
- Represent Programming in Cross-Functional Collaborations on R Capabilities and Systems:
- Collaborate with R user groups or developers outside BDM and R&D
- Collaborate with Biostatistics Innovation to enhance BDM’s overall R capabilities and implementation
- Collaborate with CSPV to enable and effectively support safety signal detection and cross-compound safety reviews (e.g., ILD)
- Collaborate with Clinical Development and Clinical Sciences to support effective data surveillance

Personal Skills and Professional Experience

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.