BioSpace
Overview
Join to apply for the
Senior Manager, Programming
role at
BioSpace Full-time position with remote work eligibility up to 75%; located in Cambridge, MA. Responsibilities
Lead clinical studies and manage external full-service provider (FSP) resources to the study. Organize and prioritize programming activities including production and quality control of datasets and outputs in accordance with internal SOPs. Assign and oversee day-to-day work of study FSPs and monitor prioritization; participate in weekly Study Execution Team (SET) meetings. Oversee external CROs to ensure programming milestones, timelines, and deliverables meet quality standards. Collaborate with internal cross-functional teams (statistics, data management, clinical operations, medical writers) to ensure timely and high-quality study deliverables. Apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, and clinical trial methodologies to maintain regulatory compliance and data reporting standards. Create and review specifications for SDTM and ADaM datasets per CDISC IG and FDA TCG guidelines. Contribute to process improvement initiatives for standard outputs; review CRF designs for protocol alignment and appropriate controlled terminology. Review Data Transfer specifications, Data Validation Plans, and related study documents to ensure compliance with study requirements. Analyze clinical trial data by creating Tables, Listings and Figures using SAS per the Statistical Analysis Plan; perform analyses such as ANCOVA, ANOVA, MMRM, logistic regression, survival analysis, and multiple imputations. Develop electronic submission packages (Define.xml, cSDRG, ADRG) for regulatory authorities and support post-submission activities. Build macros in SAS to improve efficiency and output quality; plan and resource for on-time delivery of project deliverables; ensure clear communication across teams. Qualifications
Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field, and 8 years of related experience. Experience in program analysis, quality control 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 submission to FDA/EMA/PMDA or other agencies (e.g., eCRTs, ISS, ISE, BIMO, P21 checks); provide support for regulatory questions. Experience leading and organizing study-level programming and oversight for analysis of clinical trial data, ensuring quality and timeliness. Proficiency with SAS (e.g., Freq, Univariate, Means, sgplot) for statistical analyses. Must live within normal commuting distance of the worksite; up to 75% remote work allowed. Full time.
$133,000 - $228,000
per year. Competitive compensation and benefits. Qualified applicants can apply at
https://jobs.takeda.com . Please reference job #R0147940. EOE Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time
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Join to apply for the
Senior Manager, Programming
role at
BioSpace Full-time position with remote work eligibility up to 75%; located in Cambridge, MA. Responsibilities
Lead clinical studies and manage external full-service provider (FSP) resources to the study. Organize and prioritize programming activities including production and quality control of datasets and outputs in accordance with internal SOPs. Assign and oversee day-to-day work of study FSPs and monitor prioritization; participate in weekly Study Execution Team (SET) meetings. Oversee external CROs to ensure programming milestones, timelines, and deliverables meet quality standards. Collaborate with internal cross-functional teams (statistics, data management, clinical operations, medical writers) to ensure timely and high-quality study deliverables. Apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, and clinical trial methodologies to maintain regulatory compliance and data reporting standards. Create and review specifications for SDTM and ADaM datasets per CDISC IG and FDA TCG guidelines. Contribute to process improvement initiatives for standard outputs; review CRF designs for protocol alignment and appropriate controlled terminology. Review Data Transfer specifications, Data Validation Plans, and related study documents to ensure compliance with study requirements. Analyze clinical trial data by creating Tables, Listings and Figures using SAS per the Statistical Analysis Plan; perform analyses such as ANCOVA, ANOVA, MMRM, logistic regression, survival analysis, and multiple imputations. Develop electronic submission packages (Define.xml, cSDRG, ADRG) for regulatory authorities and support post-submission activities. Build macros in SAS to improve efficiency and output quality; plan and resource for on-time delivery of project deliverables; ensure clear communication across teams. Qualifications
Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field, and 8 years of related experience. Experience in program analysis, quality control 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 submission to FDA/EMA/PMDA or other agencies (e.g., eCRTs, ISS, ISE, BIMO, P21 checks); provide support for regulatory questions. Experience leading and organizing study-level programming and oversight for analysis of clinical trial data, ensuring quality and timeliness. Proficiency with SAS (e.g., Freq, Univariate, Means, sgplot) for statistical analyses. Must live within normal commuting distance of the worksite; up to 75% remote work allowed. Full time.
$133,000 - $228,000
per year. Competitive compensation and benefits. Qualified applicants can apply at
https://jobs.takeda.com . Please reference job #R0147940. EOE Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time
#J-18808-Ljbffr