Manager, Statistical Programming (m/f)d)
Daiichi Sankyo, Township of Bernards, NJ, United States
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr