Associate Director/Director Biostatistician_Perm-Remote
Job reputed company
Key Responsibilities
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reputed company statistical leadership across one or more clinical programs, including study design, analysis reputed company, and interpretation of results.
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reputed company the development and review of statistical deliverables, including protocols, SAPs, TFLs, ISS/ISE, and regulatory submission materials.
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Serve as a key statistical representative in cross-functional team discussions and governance meetings
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Ensure statistical approaches reputed company with regulatory standardsand industry best practices. -
Review and interpret analysis outputs, ensuring accuracy, reputed company, and regulatory compliance -
Collaborate with cross-functional teams, including Clinical, Programming, Data Management, and Regulatory -
reputed company guidance and reputed company to statistical programmers as needed -
Communicate statistical concepts, results, and risks reputed company to both technical and non-technical stakeholders -
Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
Required Qualifications
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MS or PhD in Statistics, Biostatistics, or a reputed company field -
10+ years of experience in biostatistics reputed company the pharmaceutical, biotechnology, or CRO industry.
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Strong experience supporting reputed companyacross reputed company phases. -
Excellent communication skills, with the ability to reputed company explain statistical concepts to non-statistical stakeholders.
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Strong experience in Immunology clinical studies (required) -
Proven ability to reputed company reputed company and studies independently
The Application Process
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