Senior Director, Biostatistics
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Spyre TherapeuticsBiotechnology, immunology
US- RemoteFull-TimeDirector
SalaryThe expected salary range offer for this role is $295,000 to $314,000.
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Job Details
- Experience
- At least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry
- Required Skills
- R
Requirements
- PhD in Biostatistics, Statistics, or a related field.
- At least 10-12 years of biostatistics experience in the pharmaceutical, biotech, or CRO industry.
- Strong knowledge of statistical methodologies and their application in clinical trials and health research.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Proficiency in statistical software such as SAS or R.
- Experience with data management systems.
- Experience with CDISC, including SDTM, ADaM, and CDASH.
- Ability to work independently in a matrixed organization and provide solutions to emerging problems.
- Ability to collaborate in a multidisciplinary team environment.
- Working knowledge of Bayesian methodology is preferred.
Responsibilities
- Lead the program-level biometrics team, including statisticians, data managers, and statistical programmers.
- Provide statistical input to strategic planning, study design, protocol development, sample-size calculations, CRFs, results interpretation, and clinical study reports.
- Address questions from regulatory agencies and contribute to global Health Authority documents and interactions.
- Promote research into advanced and innovative statistical methods for clinical studies.
- Author and develop statistical analysis plans and coordinate specifications for derived variables and templates for statistical tables, figures, and listings.
- Guide study teams on statistical activities and collaborate with data managers to support high-quality data.
- Work with cross-functional teams and vendors to meet project deliverables and timelines.
- Oversee CRO and vendor procedures, deliverables, accuracy, and timelines.
- Coordinate statistical analyses for investigator brochures, DSUR updates, periodic safety updates, and ad hoc requests.
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