ASSOCIATE DIRECTOR, BIOMETRICSSUMMARY:The Associate Director, Biometrics is an experienced leadership position requiring broad knowledge and sound judgement within biostatistics. One will be responsible for the Biostatistics components of each assigned project, including study design, documents review for other functions, statistical analysis results, and oversee CRO. In each clinical development across indications, this role is contributing to therapeutic area strategy to ensure operational efficiency of Biostatistics elements and high scientific integrity.
RESPONSIBILITIES: - Provide statistical leadership and independent guidance for assigned clinical development programs/projects, including study design, analysis, interpretation, and development strategy.
- Serve as the statistical lead on cross-functional study and project teams and provide recommendations on complex statistical issues.
- Lead statistical strategy and execution across assigned studies, ensuring scientific rigor, consistency, and alignment with regulatory and industry standards.
- Design clinical trials and provide sound statistical guidance on clinical development projects
- Provide sample size estimates for proposed studies
- Write statistical section of study protocols, statistical analysis plans and study reports
- Develop clinical trial randomization
- Review study protocols, CRFs, database structures, study reports and annual reports
- Lead study or project team in the review and discussion of SAP
- Oversee CRO statistical activities and deliverables, including quality, timelines, and implementation of statistical analysis plans.
- Maintain study documentation of statistical analyses and supportive documents
- Other duties as assigned
REQUIREMENTS: - PhD degree in Statistics, Biostatistics or related field, and at least 5 years of relevant experience, or a master's degree in Statistics, Biostatistics or related field, and at least 8 years of relevant experience
- Proficient with SAS programming and other statistical software (e.g., R)
- Proven knowledge of CDISC (Clinical Data Interchange Standards Consortium) standards and application of those standards to projects
- Demonstrates advanced oral and written communication skills
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004094
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $164,760 to $222,888
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
