Senior Manager, Programming Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge. Job Description Pursuant to Section 20C.F.R. 656.10, you are hereby notified that an application forAlien Employment Certification will be filed by Takeda DevelopmentCenter Americas, Inc.

for the following job opportunity:

JOBLOCATION

Cambridge, MA

POSITION

: Senior Manager, Programming

POSITION DESCRIPTION

: Takeda Development Center Americas, Inc. isseeking a Senior Manager, Programming with the following duties:

Lead clinical studies, assigns and manages external full-serviceprovider (FSP) resources to the study, organize and prioritizeprogramming activities including production and quality control ofdatasets and outputs while following internal standard operatingprocedures (SOP); accountable for work assignments of study FSPsand day-to-day prioritization; participate in the weekly StudyExecution Team (SET) meetings; oversee external clinical researchorganization (CRO) to ensure they meet programmingmilestones/timelines and high quality of programming deliverables;collaborate and communicate effectively with internalcross-functional teams such as statistics, data management,clinical operations, and medical writers to ensure studydeliverables are on time with high quality; apply advancedknowledge of CDISC standards (SDTM and ADaM), medical terminology,clinical trial methodologies to ensure the compliance withregulatory agencies and data reporting standards; create and reviewspecifications for SDTM and ADaM datasets as per

CDISC IG

(Implementation guide) and FDA TCG (Technical conformance Guide);contribute to process improvement initiatives for creating standardoutputs; review CRF designs to ensure they meet the protocolcriteria, checking if appropriate controlled terminology was usedand all data required to support a high-quality database andplanned analysis are collected; review Data Transferspecifications, Data Validation Plans, and various other studydocuments and ensure they meet the study requirements; analyzeclinical trial data by creating Tables, Listings and Figures usingSAS 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 (MixedModel for Repeated Measures),logistic regression, survival analysisand Multiple Imputations; develop electronic submission packages(Define.xml for CDISC standards, cSDRG and ADRG) for regulatoryauthorities; support post submission activities; build general andproject level macros using SAS to increase efficiency and qualityof data and outputs; responsible for planning and resourcing foron-time delivery of project deliverables and ensures clearcommunication; Must live within normal commuting distance of theworksite. Up to 75% remote work allowed.

REQUIREMENTS

Bachelor’sdegree in Statistics, Math, Pharmaceutical Sciences, or relatedfield, and 8 years of related experience.

Prior experience mustinclude:

Program analysis programs and quality control checks ofanalysis datasets, dataset specifications, statistical tables,figures, and listings for clinical trials and create standardmacros that can be adapted to multiple studies; Preparedeliverables for regulatory submission to FDA/EMA/PMDA or otheragencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and providingsupport for regulatory questions; Lead and organize study levelprogramming and oversight activities for analysis of clinical trialdata, ensuring quality and timeliness; Perform statistical analysisusing various SAS procedures such as Freq, Univariate, Means,sgplot procedures. Must live within normal commuting distance ofthe worksite. Up to 75% remote work allowed. Full time. $133,000 -$228,000 per year. Competitive compensation and benefits.

Qualifiedapplicants can apply at https:

//jobs.takeda.com . Please referencejob

R0147940. EOE

Any individual may provide documentary evidencebearing on this application, with information on available workersand information on wages and working conditions, to the CertifyingOfficer, U.S. Department of Labor, Employment and TrainingAdministration, Office of Foreign Labor Certification, 200Constitution Avenue, NW, Room N-5311, Washington, DC 20210.Locations Boston, MA Worker Type Employee Worker Sub-Type RegularTime Type Full time