[Hiring] Manager, Programming @Takeda

Role Description

Takeda Development Center Americas, Inc. is seeking a Manager, Programming with the following duties:

• Lead study-level statistical programming and related oversight activities to ensure timely delivery of high-quality and compliant clinical study outputs.
• Plan, coordinate, and drive programming activities within assigned study teams, including development and review of analysis datasets, tables, listings, figures, data transfers, and submission-supporting deliverables.
• Own assigned tasks, manage priorities independently, identify risks or issues, and actively seek input from appropriate stakeholders to support effective resolution.
• Collaborate cross-functionally with Statistics, Data Management, Clinical Operations, Medical, and external partners to progress study deliverables and achieve project objectives.
• Apply strong technical and programming expertise, including advanced statistical programming and knowledge of other analytical tools as applicable, to develop efficient and accurate programming solutions.
• Utilize strong knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulatory requirements to support clinical development and regulatory compliance.
• Provide input to programming decisions and strategic discussions at the study level, including recommendations related to standards, data quality, timelines, and deliverable execution.
• Contribute to process improvement, standardization, automation, and innovation initiatives within Statistical Programming.
• Communicate complex programming concepts clearly to technical and non-technical stakeholders, influence study team decisions, and support effective collaboration across functions, regions, and cultures.
• Serve as a proactive contributor and team player by taking initiative, delivering on commitments, and supporting best practices within the statistical programming function.
• Up to 100% remote work allowed from anywhere in the U.S.

Qualifications

• Master’s degree in Statistics, Mathematics, Biostatistics, Computer Science, Data Science, Business Analytics, or related field, plus 4 years of related experience, OR
• Bachelor’s degree in Statistics, Mathematics, Biostatistics, Computer Science, Data Science, Business Analytics, or related field, plus 6 years of related experience.

Requirements

• Develop SDTM and ADaM datasets in compliance with CDISC standards and regulatory submission requirements for clinical trial studies.
• Program and perform quality control of CDISC-compliant analysis datasets, dataset specifications, and statistical tables, listings, and figures (TLFs) using SAS, R and other analytical tools.
• Create reusable macros applicable across multiple studies.
• Prepare deliverables for regulatory submissions to FDA, EMA, PMDA, and other health authorities, including ISS, ISE, BIMO analyses, and P21 validation checks.
• Provide support for regulatory questions.
• Perform statistical analyses of clinical trial data using SAS procedures including FREQ, UNIVARIATE, MEANS, LOGISTIC, GLM, MIXED, and LIFETEST to support efficacy and safety evaluations.
• Lead end-to-end statistical programming activities for clinical trials, including development of analysis datasets, TLFs, integrated summary reports (ISS/ISE), and regulatory submission deliverables, while ensuring compliance with CDISC standards, quality requirements, and timelines.

Benefits

• Medical, dental, and vision insurance
• 401(k)
• Paid time off
• Sick leave
• Company holidays
• Incentive compensation programs
• Other benefits offered under company policies