Senior Director, Biostatistics
$275,000–$290,000 year
RemoteUnited States
Job Summary
Lead the biometrics team including statisticians, data managers, and statistical programmers at a program level. Provide statistical input to strategic planning, study design, protocol development, and sample size calculations. Author statistical analysis plans, develop specifications for derived variables, and manage vendors to deliver analysis results and data files. Review and interpret clinical trial data, prepare documents for global Health Authority interactions, and coordinate ad-hoc analyses for IB and DSUR updates. Establish biostatistical processes and standards while collaborating with Clinical Development, Operations, and Regulatory teams to meet project deliverables.
Required Qualifications
- 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 and health research
- Experience with regulatory submissions and interactions with regulatory agencies
- Proficiency in statistical software (e.g., SAS, R) and data management systems
- Experience with CDSIC including SDTM, ADaM, CDASH
- Successful track record of working independently in a matrixed organization and providing solutions to emerging problems
- Excellent communication and interpersonal skills, along with organizational skills
- Ability to work collaboratively in a multidisciplinary team environment
Desired Qualifications
- Working knowledge of Bayesian methodology
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