Associate Director, Biostatistics
HybridPlymouth Meeting, Pennsylvania, United States
Job Summary
Support clinical development teams on statistical elements of study design, analysis, and decision-making by advising on methodologies, performing modeling and simulations, and leveraging external experts. Contribute to the development and evaluation of technical infrastructure and the selection of statistical methodologies, while reviewing project documents to ensure optimal presentation and compliance. Facilitate the creation of standards for key variables, definitions, and data structures, and prepare statistical aspects for meetings with regulatory authorities and key opinion leaders. Interact with clinical teams to determine protocol design and evaluate databases to determine optimal technical solutions. Maintain awareness of new statistical methodologies and regulatory guideline updates to signal relevant developments to project teams.
Required Qualifications
- Master's Degree in Biostatistics
- 5+ years of experience in applying statistical methods in biomedical research
- 3+ years of pharmaceutical and/or CRO experience
- 3+ years of ADaM experience
- Experience in all aspects of statistics for clinical trials
- Experience in working as a member of a project team
- Design of clinical studies
- Strong understanding of the various functions and expert groups contributing to Drug Development
- Strong programming skills in SAS
- Close vision
- Manual dexterity to use computers, tablets, and cell phone
- Ability to occasionally lift and/or move more than 20 pounds
- Domestic travel up to 5% of the time
- Continuous sitting for prolonged periods
Desired Qualifications
- PhD
- Experience with all stages of clinical development, especially late stage experience
- Advanced and broad knowledge of statistical methods
- Thorough understanding of industry practices related to the statistical analysis of clinical data
- Advanced knowledge in a variety of statistical methods with applications in clinical development
- Experience in statistical and data requirements for health authorities such as FDA
- Experience in statistical and data requirements for European regulatory bodies and PMDA
- Proficiency with R programming
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