Redbock - an NES Fircroft company · 1 day ago
Senior Statistical Programmer
United States
Contract
Remote
Senior Level, Lead/Staff
$85/hr - $100/hr
12+ years expRedbock, an NES Fircroft company, is seeking a Senior Statistical Programmer to support a biotechnology leader on the east coast. The FSP Manager will lead assigned studies and manage FSP programmers, balancing hands-on programming work with managerial responsibilities.
BiotechnologyMedical DeviceConsultingPharmaceutical
Hiring Manager
Tony Nicolosi
Responsibilities
Study Lead Responsibilities: Responsible for leading in-house study
Provide programming support for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs
Perform validation and QC of the programs, datasets and statistical reports per study requirements
Program and validate ADaM datasets for both safety and efficacy analyses is required
Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components
FSP Line management responsibilities: reporting to a client FTE manager, will work in client system and processes as the functional programming workstream FSP lead responsible for trial deliverables
Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed
Participate in hiring and onboarding of operational FSP programmers
Responsibilities are not limited to the criteria listed above, and the scope of work may extend beyond the core responsibilities outlined above; therefore, the role may encompass broader duties. A willingness to embrace new challenges is considered an asset, and a flexible, proactive approach is encouraged
Qualification
Required
12+ years of Statistical Programming experience in life sciences
Demonstrated leadership experience, including serving as the Point of Contact for multiple studies and leading CRM meetings
Technical hands-on involvement in Phase I, Phase II and Phase III clinical trials, particularly within rare disease indications
Proficiency in CRF annotation and metadata documentation is essential, along with strong expertise in drafting and reviewing SDTM and ADaM specifications
Must be capable of developing and implementing edit-check macros and programs to ensure data accuracy and integrity
Recent submission experience is a must and comprehensive understanding of regulatory deliverables is expected, including P21 validation, define.xml creation, SDRG, ADRG, and BIMO listings
Experience in programming and validating ADaM datasets for both safety and efficacy analyses is required, with a willingness to provide hands-on support for efficacy programming tasks as needed
Company
Redbock - an NES Fircroft company
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
51-200 employees
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 StageTotal Funding
unknown2018-06-20Acquired
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