Biolife Plasma Services
From Biolife Plasma Services's careers page
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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’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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: Manager, Programming
POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Manager, Programming with the following duties: lead study-level statistical programming and related oversight activities to ensure timely delivery of high-quality and compliant clinical study outputs. Plan, coordinate, and drive programming activities within assigned study teams, including development and review of analysis datasets, tables, listings, figures, data transfers, and submission-supporting deliverables. Own assigned tasks, manage priorities independently, identify risks or issues, and actively seek input from appropriate stakeholders to support effective resolution. Collaborate crossfunctionally with Statistics, Data Management, Clinical Operations, Medical, and external partners to progress study deliverables and achieve project objectives. Apply strong technical and programming expertise, including advanced statistical programming and knowledge of other analytical tools as applicable, to develop efficient and accurate programming solutions. Utilize strong knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulatory requirements to support clinical development and regulatory compliance. Provide input to programming decisions and strategic discussions at the study level, including recommendations related to standards, data quality, timelines, and deliverable execution. Contribute to process improvement, standardization, automation, and innovation initiatives within Statistical Programming. Communicate complex programming concepts clearly to technical and non-technical stakeholders, influence study team decisions, and support effective collaboration across functions, regions, and cultures. Serve as a proactive contributor and team player by taking initiative, delivering on commitments, and supporting best practices within the statistical programming function. Up to 100% remote work allowed from anywhere in the U.S.
Estimated salary range reflects expected pay for this role. Actual base salary depends on the applicant’s qualifications, experience, skills, education, certifications, & work location, & will comply with all applicable minimum‑wage laws. U.S. employees may be eligible for medical, dental, & vision insurance, 401(k), paid time off, sick leave, company holidays, incentive compensation programs, & other benefits offered under company policies.
REQUIREMENTS: Master’s degree in Statistics, Mathematics, Biostatistics, Computer Science, Data Science, Business Analytics, or related field, plus 4 years of related experience, OR Bachelor’s degree in Statistics, Mathematics, Biostatistics, Computer Science, Data Science, Business Analytics, or related field, plus 6 years of related experience. Prior experience must include: develop SDTM and ADaM datasets in compliance with CDISC standards and regulatory submission requirements for clinical trial studies; program and perform quality control of CDISC-compliant analysis datasets, dataset specifications, and statistical tables, listings, and figures (TLFs) using SAS, R and other analytical tools; create reusable macros applicable across multiple studies; prepare deliverables for regulatory submissions to FDA, EMA, PMDA, and other health authorities, including ISS, ISE, BIMO analyses, and P21 validation checks; provide support for regulatory questions; perform statistical analyses of clinical trial data using SAS procedures including FREQ, UNIVARIATE, MEANS, LOGISTIC, GLM, MIXED, and LIFETEST to support efficacy and safety evaluations; lead end-to-end statistical programming activities for clinical trials, including development of analysis datasets, TLFs, integrated summary reports (ISS/ISE), and regulatory submission deliverables, while ensuring compliance with CDISC standards, quality requirements, and timelines.
Full time. $116,000 to $182,270 per year.
Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0194259. 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.
Boston, MA