Senior Director, Biostatistics
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Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeDirector
Salary$275,000 to $290,000
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Job Details
- Experience
- 10-12 years
- Required Skills
- R
Requirements
- PhD Degree in Biostatistics, Statistics, or a related field.
- At least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.
- Strong knowledge of statistical methodologies and their application in clinical trials.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Proficiency in statistical software including SAS and R.
- Experience with CDISC standards including SDTM, ADaM, and CDASH.
- Ability to work independently in a matrixed organization.
- Working knowledge of Bayesian methodology is preferred.
Responsibilities
- Lead the biometrics team including statistician, data manager, and statistical programmer at a program level.
- Provide statistical input to strategic planning, study design, protocol development, sample size calculation, and clinical study reports.
- Author and develop Statistical Analysis Plans (SAPs) and work with vendors to develop specifications for derived variables, tables, figures, and listings.
- Contribute to regulatory submissions and coordinate interactions with global Health Authorities.
- Ensure high-quality data through close collaboration with data managers and oversee CRO/vendor performance.
- Coordinate the preparation of statistical analyses for Investigator's Brochures (IB), Development Safety Update Reports (DSUR), and other ad-hoc analyses.
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