The Sr. Biostatistician is responsible for statistical activities in support of clinical trials, including contributing to the statistical sections of protocols, preparing statistical analysis plans, reviewing and interpreting the analysis of clinical trial data, and QC and validation of results. Works closely with other Biostatisticians, Programmers, Data Management, Physicians, Clinical Operations, Safety, Regulatory, Research, and other related disciplines.
Oversees production of, or contributes to statistical sections of protocols, clinical study reports, and statistical analysis plans
Generates or validates sample size/power calculations and randomization schemes
Performs quality control checks of SAS code and output produced by Statistical Programmers
Performs ad-hoc and exploratory statistical analyses as needed
Represents Statistics within clinical study teams
Works closely with Data Management and Stat Programming, to ensure final databases, analyses, and reports are accurate
Participates in other activities and meetings to support Biostatistics and the Development Team as needed
Master's degree in biostatistics or statistics, with at least 4-5 years of directly related experience in the pharmaceutical industry; Ph.D. with at least 5 years of experience
Knowledge of drug development process and regulatory requirements, including ICH/GCP guidelines
Excellent verbal and written communication skills
Ability to work independently and as a team member
Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint), capable of preparing presentation materials
Fluent in spoken and written English
Familiarity with CDISC-SDTM-ADaM data standard specifications
Phase 3 clinical trial experience
NDA submission experience; ISS/ISE
Proficient in running simulations using either SAS or R
Corbus is a close-knit team of over 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, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.
Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.
Corbus Pharmaceuticals Holdings, Inc.