Corbus Pharmaceuticals Senior Director/Director Biostatistics in Norwood, Massachusetts
· Design, develop, and apply biostatistical systems and programs to support all drug development and clinical trial activities
· Deliver high quality bio-stat support and guidance and recommendations to internal and external professional staff, including senior management
· Provide bio-stat expertise in regulatory submission planning and preparation, and respond to queries and follow up requests from regulatory agencies or internal staff
· Provide input into study design, efficacy and safety parameters and planned statistical analyses.
· Assist in protocol development
· Work creatively and cooperatively and provide internal expertise to data management, programming and clinical operations and medical staff.
· Undergraduate degree with bio-statistics with PhD preferred.
· Eight of more years bio-pharma and / or CRO experience providing knowledge and expertise in bio-stat requirements for the drug development process
· Knowledge of ICH guidelines and regulatory requirements U.S. and Europe including direct experience with all submission activities
· Understanding of advanced statistical methodology and the ability to explain key principals to non bio-stat staff
· Project management skills
· Understanding of statistical reporting and analysis required for all aspects of clinical studies with an innovative approach to problem solving
Corbus is a close-knit team of nearly 150 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.
You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Company's lead product candidate, Lenabasum (Anabasum), is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.