Director, Biostatistics
Cambridge, Massachusetts /
Biology & Translation /
Full Time
/ Hybrid
To date, the collective research on transcription factors has been elusive to drug discovery. Flare Therapeutics, an early-stage biotech, has now reached a moment of light - with the prospect of forever changing the trajectory of how we treat disease. We are trailblazing the path to transcription factors by intervening at a previously hidden region we have identified as the 'switch site.' Join us and help illuminate the path to the possible. We need you.
Join an agile multidisciplinary team meeting the future precision medicine-driven drug discovery today. Be part of a team at the intersection of pre-clinical, translational studies & early clinical program advancement leveraging molecular real-world data and applying next-gen disruptive technology to bridge the bench to patient paradigm. The Director will play a key role in driving clinical biomarker statistical strategy and implementation as well as lead the company’s pre-clinical statistical activities.
In this role you will...
- Contribute to statistical activities that support clinical trials
- Act as technical SME to support trial design, data analysis and statistical interpretation of patient selection, PK/PD and exploratory biomarkers
- Deliver analytical support for biomarker data sets informing clinical trials and testing research and translational hypothesis for clinical-stage assets
- Prepare statistical analysis plans (SAPs) in support of clinical study protocols, including table, figure, and listing (TFL) shells.
- Oversee and direct data preparation and integration plans, and prepare analysis plans for exploratory objectives and clinical associations within the study protocol, as well as external partnerships/initiatives
- Establish and maintain pre-clinical data analysis best practices and lead statistical analyses that support pipeline assets
- Lead discussions on how to design experiments in general and provide guidance in specific cases
- Identify appropriate statistical approaches and deliver analytics in support of exploratory and/or translational research
- Effectively communicate best practices
- Ensure reproducibility of statistical analyses
- Manage external statistical teams
- Serve as a liaison between internal program teams and external analytics CROs
- Manage workload and deliverables from CROs and consultants
- Evaluate external analytics
- Participate in/perform the design of analysis plans for external statistical analyses
- Evaluate methods used to generate external data sources (publications, public databases, etc.)
- Lead the evaluation of advanced analytics methods
- Recommend appropriate advanced or novel analytics methods to be developed, implemented or used (state-of-the-art ML/AI methods, for example)
About you…
- You have a PhD in Biostatistics, Applied Mathematics, Epidemiology or Statistics, or equivalent experience in an industry context with a Master’s degree
- You have knowledge of the regulatory environment and SAS, and have previously participated in clinical trial work
- You have experience with various statistical methods frequently used to analyze biological systems (mixed models, time series analysis, multiple factor analysis, decision trees, neural networks, etc.)
- You may have knowledge of statistical methods in human/cancer genetics
- You may also have had exposure to statistical analysis in support of clinical diagnostic development
- You have a demonstrated proficiency with Git, R and/or Python, and other modern DevOps practices
- You have experience with AWS, and possibly even HPC and container orchestration
- You have a demonstrated track record of complex problem solving, critical thinking and leading others to achieve novel insights
- You have the capacity to manage ambiguity and uncertainty, within a fast growing, dynamic and risk-taking environment with resiliency, higher order multitasking skills and self-motivation
- You have strong communication skills, both written and verbal, in particular delivering compelling scientific narratives attuned to a particular audience
- You have a passion for driving a culture of innovation
- You have a love for science and a sense of humor
Flare is proud to foster a diverse, equitable and inclusive company culture that embraces all people that are essential to who we are, what we do and what we believe. Flare Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
TO ALL AGENCIES: Please, no phone calls or emails to any employee of Flare about our openings. All resumes submitted by search firms/employment agencies to any employee at Flare via email, the internet or in any form and/or method will be deemed the sole property of Flare, unless such search firms/employment agencies were engaged by Flare for this position and a valid agreement with Flare is in place. In the event a candidate who was submitted outside of the Flare agency engagement process is hired, no fee or payment of any kind will be paid.
