Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
The Clinical Development team at Eikon is seeking a Sr. Director of Biostatistics to support drug development activities and decision-making inclusive of phase I/II/III studies. In this role, you will report to the Head of Biostatistics and Statistical Programming.
You will serve as a statistical lead in project teams. You will lead, develop, coordinate, and provide biostatistical support in early and late clinical development programs.
What You’ll Do
- Serve as statistical representative and lead in cross-functional teams for the strategic planning and execution for product development.
- Lead biostatistics in early and late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Develop individual protocols and statistical analysis plans and independently determine appropriate statistical methodology for analyses.
- Analyze data and interpret results from clinical trials to meet objectives of the study protocol. Independently apply basic/complex statistical techniques to these analyses.
- Prepare oral and written reports to effectively communicate results of clinical trials to the project team, Eikon's management, regulatory agencies, or individual investigators.
- Provide statistical input and content in support of regulatory interactions and submissions, and represent biostatistics in regulatory interactions.
- Work closely with functional partners (e.g., Clinical, Regulatory, Data Management, Clinical Operation) to ensure an integrated and strategic approach to flawless execution.
- Work closely with Clinical, Regulatory and Clinical Operation to address questions from health authorities, investigators, and ethics committees in a consistent fashion.
- Participate in departmental activities/initiatives and research forums.
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 10 years of clinical research and drug development experience, or a Master’s degree with a minimum of 14 years relevant work experience
- Recent experience working in the field of oncology
- In-depth knowledge of statistical analysis methodologies and experimental design
- Strong scientific leadership in design and analysis of clinical trials
- Solid knowledge of statistical and data processing software e.g., SAS and R
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase I to III studies
- Excellent oral and written communication skills and strong leadership in a team environment
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development
- Demonstrated ability to be proactive, self-motivated, strategic, and capable of driving results
- Publications in peer reviewed statistical/medical journals
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 $243,000 to $280,000 depending on skills, competency, and the market demand for your expertise.