Takeda Development Center Americas, Inc. is seeking a Senior Manager, Programming to lead clinical studies and manage external full-service provider resources, ensuring high-quality programming deliverables and compliance with regulatory agencies and data reporting standards.
Requirements
- Advanced knowledge of CDISC standards (SDTM and ADaM)
- Medical terminology
- Clinical trial methodologies
- SAS programming
- Statistical analysis using various SAS procedures such as Freq, Univariate, Means, sgplot procedures
- Experience with electronic submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities
- Experience with statistical analyses such as ANCOVA, ANOVA, MMRM, logistic regression, survival analysis and Multiple Imputations
Responsibilities
- Lead clinical studies, assigns and manages external full-service provider (FSP) resources to the study, organize and prioritize programming activities including production and quality control of datasets and outputs while following internal standard operating procedures (SOP)
- Oversee external clinical research organization (CRO) to ensure they meet programming milestones/timelines and high quality of programming deliverables
- Collaborate and communicate effectively with internal cross-functional teams such as statistics, data management, clinical operations, and medical writers to ensure study deliverables are on time with high quality
- Apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards
- Create and review specifications for SDTM and ADaM datasets as per CDISC IG (Implementation guide) and FDA TCG (Technical conformance Guide)
- Analyze clinical trial data by creating Tables, Listings and Figures using SAS as per the Statistical Analysis Plan for individual studies
- Implement statistical analyses such as (but not limited to): ANCOVA (Analysis of Covariance), ANOVA (Analysis of Variance) MMRM (Mixed Model for Repeated Measures),logistic regression, survival analysis and Multiple Imputations
Other
- Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field
- 8 years of related experience
- Must live within normal commuting distance of the worksite
- Up to 75% remote work allowed
- Full time
