Director, Biostatistics - Eikon Therapeutics : Job Details

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.

Position

Clinical Development at Eikon is seeking a Director of Biostatistics to support drug development activities and decision-making encompassing phase I/II/III studies. In this role, you will report to the Head of Biostatistics and Statistical Programming. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

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

* Serves as statistical representative and lead in the 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

* Develops individual protocols and statistical analysis plans and independently determines appropriate statistical methodology for analyses

* Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies basic/complex statistical techniques to these analyses

* Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our company'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

* Participates in departmental activities/initiatives and research forums

Qualifications

* PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 8 years of clinical research and drug development experience, or a Master's degree with a minimum of 12 years relevant work experience

* Recent experience working in the field of oncology preferred

* 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 $213,000 to $232,750 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.