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Director, Biostatistics
Spero Therapeutics | |||||||
United States, Massachusetts, Cambridge | |||||||
675 Massachusetts Avenue (Show on map) | |||||||
August 03, 2023 | |||||||
Director, Biostatistics Job Locations
US-MA-Cambridge | US
About Us Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotech and drug development experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on patients with unmet need associated with multi-drug resistant (MDR) bacterial infections. Spero's lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero's partnership directed programs consist of SPR206 and tebipenem HBr. SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections and tebipenemHBr, is an oralcarbapenembeing developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). InSeptember 2022, Spero announced an exclusive license agreement with GSK for worldwide rights of tebipenem HBr, except for Japan and certain Asian countries.
We believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings. Overview Spero Therapeutics is looking for an experienced, collaborative, enthusiastic partner responsible for ensuring the robust application of traditional and emerging statistical methodologies to support the development and execution of clinical development strategies that deliver medically differentiated therapies that provide meaningful improvement to patients. In this role, the individual will provide strategic statistical input to the design, execution, analysis, and reporting of data for clinical and nonclinical studies and regulatory submissions across all Spero programs. Working in a cross-functional manner, this individual will liaise with various internal groups (Clinical, Nonclinical, Microbiology, Regulatory Affairs, Pharmacovigilance, and Medical Affairs) and external partners, including vendors and CROs for the delivery of statistics and data programming needs. What you'll do
Oversee and be accountable for development of statistical sections of clinical study protocols, statistical analysis plans, along with data analysis, interpretation, and reporting of results for clinical study reports and related publications
What you'll need
By joining our committed and highly motivated team, you'll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero's culture is one that emphasizes "servant leadership," or putting ego aside and working for the benefit of the team and our patients, and values our colleagues' opinions and celebrates accomplishments in service of patients. Spero Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. |