Cambridge, MA, US

Company Summary

Neon Therapeutics is an immuno-oncology company focused on developing novel therapeutics leveraging neoantigen biology to treat cancer. Neon utilizes its expertise in bioinformatics, neoepitope prediction and immune monitoring to identify tumor specific mutations and monitor clinical response to their personalized vaccines.  Neon Therapeutics’ lead program is NEO-PV-01, a bespoke neoantigen vaccine that builds upon years of research and development at the Broad Institute and Dana-Farber Cancer Institute.  NEO-PV-01 is now being studied in a Phase 1b clinical trial combining the vaccine with Opdivo®, a PD-1 immune checkpoint inhibitor from Bristol-Myers Squibb, in patients with measurable metastatic melanoma, non-small cell lung cancer and bladder cancer.  Also in development are NEO-PTC-01, a bespoke autologous T cell therapy, and a Shared Neoantigen Program leveraging neoepitopes that are common across patients and tumor types.

In addition, Neon has established strategic partnerships with CRISPR, Merck, and Apexigen, among others.  By the end of 2018, it is anticipated there will be multiple clinical programs utilizing Neon’s platform.

Neon Therapeutics was incubated and launched by Third Rock Ventures, raised a $55M Series A in 2015 and, more recently, a $106M Series B in December 2017, and has filed for an initial public offering.

Position Summary

The statistician is responsible for designing, leading and implementing statistical approaches to support all Neon clinical studies and drive decision making.  The successful candidate will function serve as a line function leader for Neon Clinical Statistics across all development programs. This person will serve as a central thought leader on trial design, reporting and resource management.  This will include the management and supervision of internal and external resources (e.g. CRO’s) to meet the reporting goals of Neon’s clinical portfolio.  Key deliverables will include authoring of SAPs, designing and programming study outputs, and conducting ad-hoc analyses and data mining.

Experience in biotechnology and/or pharmaceuticals is required; experience with clinical site interactions, regulatory and oncology phase I studies is strongly preferred. Building a track record of study success and innovative though in this role, a candidate will have fantastic opportunity for growth in taking a leadership role in the Biostatistics function at Neon.

Primary Responsibilities

  • Serve as a fine function leader for trail statistics and statistical programming for all Neon clinical development programs
  • Work to ensure that Neon development programs meet scientific, regulatory, and quality requirements
  • Perform trial statistician responsibilities such as review of protocols/amendments and regulatory interactions, authoring SAPs, reviewing CRFs, design of study outputs
  • Perform exploratory data analyses as needed, including communicating results internally/externally
  • Provide management and oversight for in-house and/or partner biostatisticians/programmers
  • Apply innovative analytical approaches to data exploration, study design and methodologies
  • Plan, monitor and drive study level activities for all Neon clinical trials, ensuring all timelines are met with high quality
  • With Clinical Data Management, help build and implement data standards
  • Mentor other team members/partners as required

Experience and Essential Skills

  • PhD in Biostatistics or related discipline with 3+ years biopharmaceutical industry experience; MS in Biostatistics or related discipline with extensive industry and leadership experience will be considered
  • Proven knowledge and expertise in statistics and its applications to clinical trials
  • Strong programming skills, including SAS and/or R.
  • Experience with clinical trial statistics is required, including prior experience as a program statistician
  • Experience in communicating statistics to external parties, such as IRB’s or regulatory organizations
  • Ability to serve a key role on a multifunctional clinical trial team.
  • Strong ability to work independently
  • Excellent verbal/communication skills
  • Track record of innovative thought and ability of exploring novel approaches to clinical trial statistics and programming.

Core Values

At Neon Therapeutics, our core values drive our actions ever day. Successful candidates will demonstrate and embody our company’s commitment to:

  • Patients: Urgently develop life-changing medicines
  • People: Listen, Learn, Teach
  • Science: Creative, Rigorous, Uncompromising
  • Tenacity: Persevere, Build Neon to last
  • Pioneer: Leave the comfort zone, Create the future
  • Integrity: Do RIGHT

Equal Employment Opportunity

Neon Therapeutics provides equal employment opportunities to all employees and applicants for employment without regard to race, color, national origin, religion, sexual orientation, gender, gender identity or expression, age, veteran status, disability, or genetics. In addition to federal law requirements, Neon Therapeutics complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.