Senior Statistical Programmer jobs in United States
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Redbock - an NES Fircroft company ยท 1 month ago

Senior Statistical Programmer

positionUnited States
timeContract
remoteRemote
senioritySenior Level, Lead/Staff
date12+ years exp

Redbock - an NES Fircroft company is seeking a Senior Statistical Programmer with strong industry experience primarily on the Sponsor side. The role involves independently creating define.xml files, developing SDTM and ADaM specifications, and managing statistical programming activities for clinical studies and regulatory submissions.

BiotechnologyConsultingMedical DevicePharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Shanna Blue
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Responsibilities

Support statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines
Maintain statistical programming standards, processes, and SOPs
Manage CRO and review deliverables for accuracy and compliance, performing perform acceptance check and validation
Manage, review, and/or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations, and regulatory query responses, covering multiple studies
Generate TFLs to support ad hoc requests
Review data management documents (CRF specification, data transfer agreements, DMP, annotated CRF), SDTM and ADaM specification, SAP, and TFL shells to provide statistical programming feedback

Qualification

Statistical programmingDefine.xml creationSDTMADaM specificationsRegulatory submissionsPinnacle 21Submission package experienceLeadership skillsCollaboration skills

Required

12-15+ years of statistical programming experience in the pharma/biotech industries working for Sponsor companies
Expertise with define.xml and able to create define.xml in the newest version of pinnacle 21 from scratch
Submission package experience (generating SDRG/ADRG, p21, define.xml, eCRF, reviewers guide etc)
Must be able to independently develop SDTM and ADaM specifications (DDT) and program, develop and validate TFLs
Must have worked on a submission within the last year or two
Define package experience and ISS/ISE experience
Experience leading and managing statistical programming activities for clinical trials and regulatory submissions
Strong experience with regulatory submissions activities (BLA/NDA)

Company

Redbock - an NES Fircroft company

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Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
dateFounded in 2010
location
Cupertino, California, USA
people-size51-200 employees
web-link
http://redbock.com/

H1B Sponsorship

Redbock - an NES Fircroft company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2018-06-20Acquired
Company data provided by crunchbase