BioSpace
Overview
Senior Manager, Programming at Takeda Development Center Americas, Inc. Location: Boston, MA (Cambridge, MA as noted in original). Up to 75% remote work allowed. Full-time position. Salary range: $133,000 - $228,000 per year. EOE. Responsibilities
Lead clinical studies, assign and manage external full-service provider resources to the study; organize and prioritize programming activities including production and quality control of datasets and outputs in accordance with internal SOPs. Accountable for work assignments of study FSPs and day-to-day prioritization; participate in the weekly Study Execution Team (SET) meetings; oversee external CRO to ensure programming milestones and high quality deliverables. Collaborate 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, and clinical trial methodologies to ensure compliance with regulatory agencies and data reporting standards; create and review specifications for SDTM and ADaM datasets as per CDISC IG and FDA Technical Conformance Guide. Contribute to process improvement initiatives for creating standard outputs; review CRF designs to ensure they meet protocol criteria and appropriate controlled terminology is used; ensure data required to support a high-quality database and planned analyses are collected. Review Data Transfer specifications, Data Validation Plans, and other study documents to ensure they meet study requirements; analyze clinical trial data by creating Tables, Listings and Figures using SAS as per the Statistical Analysis Plan; implement statistical analyses (e.g., ANCOVA, ANOVA, MMRM, logistic regression, survival analysis, multiple imputations). Develop electronic submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities; support post-submission activities; build SAS macros to increase efficiency and quality of outputs. Plan and resource for on-time delivery of project deliverables with clear communication; must live within normal commuting distance of the worksite. Qualifications
Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field, and 8 years of related experience. Experience in program analysis, QC checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials; ability to create standard macros adaptable to multiple studies. Experience preparing deliverables for regulatory submissions to FDA/EMA/PMDA or other agencies and providing support for regulatory questions; lead and organize study-level programming and oversight for analysis of clinical trial data; perform statistical analysis using SAS (e.g., Freq, Univariate, Means, sgplot). Must live within normal commuting distance of the worksite. Up to 75% remote work allowed. Locations
Boston, MA Job details
Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Employment type: Full-time
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Senior Manager, Programming at Takeda Development Center Americas, Inc. Location: Boston, MA (Cambridge, MA as noted in original). Up to 75% remote work allowed. Full-time position. Salary range: $133,000 - $228,000 per year. EOE. Responsibilities
Lead clinical studies, assign and manage external full-service provider resources to the study; organize and prioritize programming activities including production and quality control of datasets and outputs in accordance with internal SOPs. Accountable for work assignments of study FSPs and day-to-day prioritization; participate in the weekly Study Execution Team (SET) meetings; oversee external CRO to ensure programming milestones and high quality deliverables. Collaborate 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, and clinical trial methodologies to ensure compliance with regulatory agencies and data reporting standards; create and review specifications for SDTM and ADaM datasets as per CDISC IG and FDA Technical Conformance Guide. Contribute to process improvement initiatives for creating standard outputs; review CRF designs to ensure they meet protocol criteria and appropriate controlled terminology is used; ensure data required to support a high-quality database and planned analyses are collected. Review Data Transfer specifications, Data Validation Plans, and other study documents to ensure they meet study requirements; analyze clinical trial data by creating Tables, Listings and Figures using SAS as per the Statistical Analysis Plan; implement statistical analyses (e.g., ANCOVA, ANOVA, MMRM, logistic regression, survival analysis, multiple imputations). Develop electronic submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities; support post-submission activities; build SAS macros to increase efficiency and quality of outputs. Plan and resource for on-time delivery of project deliverables with clear communication; must live within normal commuting distance of the worksite. Qualifications
Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field, and 8 years of related experience. Experience in program analysis, QC checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials; ability to create standard macros adaptable to multiple studies. Experience preparing deliverables for regulatory submissions to FDA/EMA/PMDA or other agencies and providing support for regulatory questions; lead and organize study-level programming and oversight for analysis of clinical trial data; perform statistical analysis using SAS (e.g., Freq, Univariate, Means, sgplot). Must live within normal commuting distance of the worksite. Up to 75% remote work allowed. Locations
Boston, MA Job details
Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Employment type: Full-time
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