Takeda
Job Description
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity. Job Location:
Cambridge, MA Position:
Senior Manager, Programming Position Description:
Takeda Development Center Americas, Inc. is seeking a Senior Manager, Programming with the following duties: lead clinical studies, assign 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 while following 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 CROs to ensure they meet programming milestones and high-quality deliverables; collaborate with internal cross-functional teams (statistics, data management, clinical operations, medical writers) to ensure on-time, high-quality study deliverables; apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, and clinical trial methodologies to ensure regulatory and data reporting standards compliance; create and review specifications for SDTM and ADaM datasets per CDISC IG and FDA TCG; contribute to process improvements for standard outputs; review CRF designs to meet protocol criteria and ensure appropriate controlled terminology and complete data for high-quality databases and planned analyses; review Data Transfer specifications and Data Validation Plans to meet study requirements; analyze clinical trial data by creating Tables, Listings, and Figures using SAS as per the SAP; implement statistical analyses such as ANCOVA, ANOVA, MMRM, logistic regression, survival analysis, and multiple imputation; develop electronic submission packages (Define.xml for CDISC, cSDRG and ADRG) for regulatory authorities; support post-submission activities; build macros in SAS to improve efficiency and quality of data and outputs; plan and resource for on-time delivery of project deliverables and ensure clear communication; must live within normal commuting distance of the worksite. Up to 75% remote work allowed. Requirements:
Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field, and 8 years of related experience. Prior experience must include program analysis, quality checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials, and creating standard macros adaptable to multiple studies; prepare deliverables for regulatory submissions to FDA/EMA/PMDA or other agencies (e.g., eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; lead and organize study-level programming and oversight activities for analysis of clinical trial data, ensuring quality and timeliness; perform statistical analysis using SAS procedures such as Freq, Univariate, Means, and sgplot; must live within normal commuting distance of the worksite. Up to 75% remote work allowed. Employment Type & Location:
Full-time, Boston, MA; locations include Boston, MA; remote flexibility noted (up to 75% remote). Compensation:
Base pay range listed as $137,000.00/yr - $215,270.00/yr; Full-time range also noted as $133,000 - $228,000 per year in different sections. Actual pay based on skills and experience; details provided by recruiter. How to Apply & Notices:
Qualified applicants can apply at https //jobs.takeda.com. Please reference job # R0147940. EOE. By applying, you acknowledge Takeda’s Privacy Notice and Terms of Use. EEO & Legal:
Any individual may provide documentary evidence bearing on this application to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification. Locations:
Boston, MA Seniority level
Mid-Senior level Employment type
Full-time Job function
Marketing, Public Relations, and Writing/Editing Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Takeda by 2x Additional related postings: Boston, MA $133,000 - $228,000 (3 weeks ago); Greater Boston $136,000 - $170,000 (2 days ago); Senior IT Manager - Data Platform (Hybrid or Remote) Canton, MA $165,000 - $211,000 (1 month ago)
#J-18808-Ljbffr
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity. Job Location:
Cambridge, MA Position:
Senior Manager, Programming Position Description:
Takeda Development Center Americas, Inc. is seeking a Senior Manager, Programming with the following duties: lead clinical studies, assign 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 while following 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 CROs to ensure they meet programming milestones and high-quality deliverables; collaborate with internal cross-functional teams (statistics, data management, clinical operations, medical writers) to ensure on-time, high-quality study deliverables; apply advanced knowledge of CDISC standards (SDTM and ADaM), medical terminology, and clinical trial methodologies to ensure regulatory and data reporting standards compliance; create and review specifications for SDTM and ADaM datasets per CDISC IG and FDA TCG; contribute to process improvements for standard outputs; review CRF designs to meet protocol criteria and ensure appropriate controlled terminology and complete data for high-quality databases and planned analyses; review Data Transfer specifications and Data Validation Plans to meet study requirements; analyze clinical trial data by creating Tables, Listings, and Figures using SAS as per the SAP; implement statistical analyses such as ANCOVA, ANOVA, MMRM, logistic regression, survival analysis, and multiple imputation; develop electronic submission packages (Define.xml for CDISC, cSDRG and ADRG) for regulatory authorities; support post-submission activities; build macros in SAS to improve efficiency and quality of data and outputs; plan and resource for on-time delivery of project deliverables and ensure clear communication; must live within normal commuting distance of the worksite. Up to 75% remote work allowed. Requirements:
Bachelor’s degree in Statistics, Math, Pharmaceutical Sciences, or related field, and 8 years of related experience. Prior experience must include program analysis, quality checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials, and creating standard macros adaptable to multiple studies; prepare deliverables for regulatory submissions to FDA/EMA/PMDA or other agencies (e.g., eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; lead and organize study-level programming and oversight activities for analysis of clinical trial data, ensuring quality and timeliness; perform statistical analysis using SAS procedures such as Freq, Univariate, Means, and sgplot; must live within normal commuting distance of the worksite. Up to 75% remote work allowed. Employment Type & Location:
Full-time, Boston, MA; locations include Boston, MA; remote flexibility noted (up to 75% remote). Compensation:
Base pay range listed as $137,000.00/yr - $215,270.00/yr; Full-time range also noted as $133,000 - $228,000 per year in different sections. Actual pay based on skills and experience; details provided by recruiter. How to Apply & Notices:
Qualified applicants can apply at https //jobs.takeda.com. Please reference job # R0147940. EOE. By applying, you acknowledge Takeda’s Privacy Notice and Terms of Use. EEO & Legal:
Any individual may provide documentary evidence bearing on this application to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification. Locations:
Boston, MA Seniority level
Mid-Senior level Employment type
Full-time Job function
Marketing, Public Relations, and Writing/Editing Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Takeda by 2x Additional related postings: Boston, MA $133,000 - $228,000 (3 weeks ago); Greater Boston $136,000 - $170,000 (2 days ago); Senior IT Manager - Data Platform (Hybrid or Remote) Canton, MA $165,000 - $211,000 (1 month ago)
#J-18808-Ljbffr