Takeda Digital Ventures
Senior Manager, Programming
Takeda Digital Ventures - Boston, Massachusetts, us, 02298
Work at Takeda Digital Ventures
Overview
- View job
Overview
Join to apply for the
Senior Manager, Programming
role at
Takeda Digital Ventures 3 weeks ago Be among the first 25 applicants Join to apply for the
Senior Manager, Programming
role at
Takeda Digital Ventures Get AI-powered advice on this job and more exclusive features. Job Level: Senior Travel: Minimal (if any)
Read all the information about this opportunity carefully, then use the application button below to send your CV and application.
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
Back to nav
Job ID
R0147940
Date posted
04/04/2025
Location
Boston, Massachusetts
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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, 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); accountable for work assignments of study FSPs and day-to-day prioritization; participate in the weekly Study Execution Team (SET) meetings; 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); contribute to process improvement initiatives for creating standard outputs; review CRF designs to ensure they meet the protocol criteria, checking if appropriate controlled terminology was used and all data required to support a high-quality database and planned analysis are collected; review Data Transfer specifications, Data Validation Plans, and various other study documents and ensure they meet the study requirements; 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; develop electronic submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities; support post submission activities; build general and project level macros using SAS to increase efficiency and quality of data and outputs; responsible for planning and resourcing for on-time delivery of project deliverables and ensures 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 programs and quality control checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials and create standard macros that can be adapted to multiple studies; Prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and providing 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 various SAS procedures such as Freq, Univariate, Means, sgplot procedures. 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
Apply Now
Back to navSeniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionMarketing, Public Relations, and Writing/Editing IndustriesVenture Capital and Private Equity Principals Referrals increase your chances of interviewing at Takeda Digital Ventures by 2x Get notified about new Senior Programming Manager jobs in
Boston, MA . Boston, MA $137,000.00-$215,270.00 2 weeks ago Senior Manager or Associate Director, Statistical ProgrammingAssociate Director/Sr. Manager Data Analyst, Statistical Programming We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Senior Manager, Programming
role at
Takeda Digital Ventures 3 weeks ago Be among the first 25 applicants Join to apply for the
Senior Manager, Programming
role at
Takeda Digital Ventures Get AI-powered advice on this job and more exclusive features. Job Level: Senior Travel: Minimal (if any)
Read all the information about this opportunity carefully, then use the application button below to send your CV and application.
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
Back to nav
Job ID
R0147940
Date posted
04/04/2025
Location
Boston, Massachusetts
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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, 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); accountable for work assignments of study FSPs and day-to-day prioritization; participate in the weekly Study Execution Team (SET) meetings; 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); contribute to process improvement initiatives for creating standard outputs; review CRF designs to ensure they meet the protocol criteria, checking if appropriate controlled terminology was used and all data required to support a high-quality database and planned analysis are collected; review Data Transfer specifications, Data Validation Plans, and various other study documents and ensure they meet the study requirements; 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; develop electronic submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities; support post submission activities; build general and project level macros using SAS to increase efficiency and quality of data and outputs; responsible for planning and resourcing for on-time delivery of project deliverables and ensures 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 programs and quality control checks of analysis datasets, dataset specifications, statistical tables, figures, and listings for clinical trials and create standard macros that can be adapted to multiple studies; Prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and providing 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 various SAS procedures such as Freq, Univariate, Means, sgplot procedures. 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
Apply Now
Back to navSeniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionMarketing, Public Relations, and Writing/Editing IndustriesVenture Capital and Private Equity Principals Referrals increase your chances of interviewing at Takeda Digital Ventures by 2x Get notified about new Senior Programming Manager jobs in
Boston, MA . Boston, MA $137,000.00-$215,270.00 2 weeks ago Senior Manager or Associate Director, Statistical ProgrammingAssociate Director/Sr. Manager Data Analyst, Statistical Programming We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr