Manager, Statistical Programming (m/f)d)
Daiichi Sankyo, Inc.
Basking Ridge, NJ
Apply
JOB DETAILS
SKILLS
Analysis Skills, Artificial Intelligence (AI), Best Practices, Biostatistics, Biotech and Pharmaceutical, Cardiovascular Disease, Case Report Form (CRF), Clinical Assessment, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Information Systems, Clinical Practices/Protocols, Clinical Trial, Code Reviews, Computer Systems, Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Data Analysis, Data Management, Data Modeling, Data Sets, Database Analysis, Disease Immunity, Documentation, Drug Development, Healthcare, International Health, Medical Products, Oncology, Outsourcing, Problem Solving Skills, Process Improvement, Programming Languages, Project/Program Coordination, Project/Program Management, Python Programming/Scripting Language, R Programming Language, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Requirements Management, Standards Development, Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Sustainability, Team Lead/Manager, Time Management, Training Data Sets, Vendor/Supplier Evaluation, Willing to Travel
LOCATION
Basking Ridge, NJ
POSTED
Today
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 Position
The purpose of this role is to lead and contribute to statistical programming activities across SDTM, ADaM, and Tables, Listings, and Figures (TLFs), providing both technical oversight and hands-on support for the development, validation, and programmatic review of datasets and outputs. This role ensures the quality, consistency, and timeliness of deliverables supporting oncology regulatory submissions by guiding programming strategies, reviewing key outputs, and driving issue resolution. In addition, this position fosters and maintains institutional knowledge across oncology compounds, while supporting the development, standardization, and continuous improvement of programming processes and best practices for datasets and TLFs to enhance efficiency, quality, and compliance.
Roles and Responsibilities
Lead and Execute Statistical Programming
- Develop and validate datasets and Tables, Listings, and Figures (TLFs) to ensure high-quality deliverables for pivotal studies, as well as Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) for oncology regulatory submissions
- Drive end-to-end programming from SDTM through ADaM to TLF generation in compliance with CDISC standards and regulatory requirements
- Develop SDTM CRF annotations and SDTM specifications, as well as analysis dataset specifications to ensure accurate implementation of SAPs and TLF shells
- Perform hands-on programming to create and validate SDTM and ADaM datasets and TLFs, ensuring quality, integrity, and submission readiness
- Ensure datasets meet CDISC and regulatory submission standards while conducting comprehensive reviews of submission data packages to ensure quality, completeness, and alignment with regulatory expectations
Manage and Coordinate Statistical Programming Activities
- Develop and manage programming timelines and resource plans
- Collaborate closely with Biostatistics, Data Management, and cross-functional teams to ensure efficient and accurate execution
- Manage the generation and tracking of datasets and TLFs for ongoing and completed studies, ensuring appropriate data usage and high-quality outputs
- Proactively identify and resolve programming-related issues prior to database lock and analysis
- Ensure the completeness and accuracy of all study programming deliverables
- Maintain all required programming documentation in compliance with Trial Master File (TMF) requirements
Oversee Statistical Programming Vendor (Outsourced Studies)
- Review and agree on vendor project timelines and resource planning
- Work in tandem with Biostatistics and Data Management members to ensure best vendor performance
- Monitor analysis dataset and TLF transfers for ongoing and completed trials, confirming data use and output quality
- Proactively ensure the resolution of programming-related issues prior to database lock and analysis
- Verify completeness of study programming deliverables and maintain all required study programming documentation for the Trial Master File (TMF)
Maintain Institutional Knowledge and Standardized Programming Practices:
- Contribute to CRF and SDTM standard development
- Support the development, implementation, and maintenance of Analysis Data Model (ADaM) datasets and TLF standards
- Support training initiatives to ensure consistent implementation of ADaM and TLF standards in clinical trial analyses
Provide Programming Support for Regulatory Activities
- Develop TLFs to support submission-related queries with quick turnaround timelines
- Support ad hoc and exploratory analyses requested by clinical teams
- Provide programming support for regulatory responses and potential Advisory Committee meetings
Develop and Maintain Programming Macros
- Collaborate with Biostatistics team members to define requirements for efficacy data review
- Develop and enhance macros
- Support internal data review and monitoring activities
Qualifications
Education Qualifications
- Master's Degree Biostatistics or similar degree required
- PhD Biostatistics or similar degree preferred
Experience Qualifications
- 6+ years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a master’s degree required
- Oncology experience required
- Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred
- Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred
- Knowledge of all phases of drug development, including early and late phase clinical development and global submission preferred
- Experience with R and Python programming languages preferred
- Familiarity with AI/ML and their applications in clinical data analysis preferred
- Experience supporting and maintaining Statistical computing environment and clinical data repository system preferred
Travel Requirements
- Ability to travel up to 10% of the time
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
About the Company
D