Senior Manager, Programming

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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.

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