Eikon Therapeutics is seeking a skilled and highly motivated Associate Director, Biostatistics to contribute their statistical expertise and strategic thinking to the design, execution, and analysis of clinical trials and experimental studies to discover novel treatments for life-threatening diseases.
Requirements
- Proficiency in statistical programming languages (e.g., R, SAS) and experience with data visualization tools.
- Strong understanding of regulatory guidelines (ICH, FDA, etc.) and their implications on statistical analysis and reporting.
- Experience in authoring statistical analysis plans and performing statistical analyses and reporting using tables, listings, and figures.
- Experience with Bayesian statistics and adaptive trial designs.
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years of clinical research and drug development experience.
- Oncology experience is a plus.
- Publications in peer-reviewed journals showcasing contributions to the field of biostatistics.
Responsibilities
- Collaborate with interdisciplinary teams to design clinical trials, experiments, and studies, ensuring appropriate statistical methodologies are employed.
- Lead the development of statistical analysis plans, including endpoints, sample size determination, randomization strategies, and statistical methodologies.
- Perform advanced statistical analyses on complex datasets, interpreting results and drawing actionable conclusions.
- Provide guidance and mentorship to biostatisticians and statistical programmers within the team.
- Contribute to regulatory submissions by providing statistical expertise and preparing relevant sections of documents.
- Stay current with emerging trends and best practices in biostatistics and their application in the biotechnology field.
- Drive the implementation and utilization of advanced statistical tools and software.
Other
- Minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey office.
- Excellent communication skills with the ability to convey complex statistical concepts to non-technical stakeholders.
- Demonstrated leadership capabilities, including the ability to lead and mentor a team.
- Proven track record of designing and analyzing clinical trials and experimental studies, particularly within the biotechnology, pharmaceutical, or related industries.
- This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
