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Redbock - an NES Fircroft company · 6 days ago
Senior Biostatistician
United States
Contract
Remote
Senior Level
10+ years exp
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Insider Connection @Redbock - an NES Fircroft company
Responsibilities
Contribute to study design, protocol development, sample size calculation, CRFs, Results Interpretation, clinical study report, and addressing questions from regulatory agencies.
Collaborate with vendor to develop and maintain SAPs, including the derived variables, the templates of statistical TFLs.
Provide guidance to the study team for all statistical activities while collaborating with a data manager to ensure high-quality data.
Work collaboratively with cross-functional teams to ensure timelines are being met.
Manager CROs by establishing procedures through regular interaction, setting expectations on deliverables and timelines to guide vendor biostatisticians and statistical programmers.
Provide input for regulatory interaction or by writing the interaction document; may participate in meeting or teleconferences with Health Authorities.
Coordinate with all team members to prepare the statistical analyses for IB, DSUR update, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings.
Qualification
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Required
PhD in Statistics or Biostatistics AND 10+ years of biostatistics experience in the pharma/biotech industries
Must possess strong statistical programming technical expertise in SAS
Knowledge of statistical methodologies, current drug development trends, and regulatory environments
Ability to communicate effectively and interact with cross functional teams
Preferred
Experience in Phase III and late phase clinical trials and drug filings is preferred
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
Trends of Total Sponsorships
2022 (1)
2021 (7)
2020 (10)
Funding
Current Stage
Growth StageTotal Funding
unknown2018-06-20Acquired· by NES Global Talent
Company data provided by crunchbase
