Manager, Programming
Takeda
Summary
Lead study-level statistical programming and related oversight activities to ensure timely delivery of high-quality and compliant clinical study outputs.
Job description
Position Description
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.
Requirements
- 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 the same fields plus 6 years of related experience
- 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 & Vision
- 401(k)
- Paid Time Off
- Sick Leave
- Company Holidays
- Incentive Compensation Programs
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.