Senior Manager, Biostatistics

Position

We are seeking a skilled and highly motivated Senior Manager, Biostatistics, to join our talented team. The successful candidate will contribute their statistical expertise and strategic thinking to the design, execution, and analysis of clinical trials and experimental studies. In collaboration with cross-functional teams, you will lead statistical efforts that facilitate evidence-based conclusions and guide our research and development initiatives.

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.  

About You

The ideal candidate for this role should possess a proven track record of designing and analyzing clinical trials and experimental studies, particularly within the biotechnology, pharmaceutical, or related industries. This candidate excels in leading interdisciplinary teams to design studies, developing statistical analysis plans, performing advanced statistical analyses, and providing guidance to team members. Their proficiency in statistical programming languages, understanding of regulatory guidelines, and excellent communication skills are essential for conveying complex statistical concepts to non-technical stakeholders. The ideal candidate also demonstrates leadership capabilities and a deep knowledge of emerging trends and best practices in biostatistics, statistical tools, and software.

What You’ll Do

• 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.
• Collaborate with clinical trial team to support study conduct, analysis and reporting.
• Develop and/or review statistical documents for clinical trials, including table/listing/figure shells, statistical analysis, and specifications of variable derivation.
• Work collaboratively with Statistical Programmers, Clinical Research, Clinical Data Managers and other Clinical, Safety, Regulatory and Project Management colleagues to meet project deliverables and timelines for statistical data analysis and reporting.
• Independently conduct clinical trial statistical simulations; conduct ad hoc analyses if needed.
• Perform advanced statistical analyses on complex datasets, interpreting results and drawing actionable conclusions. 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.

Qualifications

• Typically requires 6 years of experience and a Master’s degree; or a PhD with 3 years experience.
• Recent experience working in the field of oncology preferred.
• Broad knowledge of statistical analysis methodologies and experimental design
• 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.
• Excellent writing and verbal communication skills with the ability to convey complex statistical concepts to non-technical stakeholders.
• Experience with Bayesian statistics and adaptive trial designs.
• Knowledge of machine learning and its application in biostatistics.
• Publications in peer-reviewed journals showcasing contributions to the field of biostatistics.
• Familiarity with cloud-based computing and big data analysis.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $164,000 to $179,550 depending on skills, competency, and the market demand for your expertise.