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 tebipenem HBr, is an oral carbapenem being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 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.

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.

• 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


• Lead accountability for effective operations in biostatistics activities across all Spero programs


• Develop high level biostatistics strategy in support of clinical development, medical affairs, pharmacovigilance activities and regulatory submissions


• Represent the company in interfaces with regulatory authorities, key opinion leaders, advisory board meetings and at scientific conferences


• Provide statistical expertise and innovative thinking to support complicated study designs in order to enhance the probability of success for clinical development programs


• Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of data relevant to Spero programs


• Engage and manage external partners (e.g., CROs, central laboratories, software vendors, etc) to ensure sponsor oversight and high-quality outputs with respect to statistical and data programming deliverables


• Review and support required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and computational methods documentation


• Stay abreast of statistical developments, methods, and technologies related to the therapeutic area knowledge in Biotech/Pharmaceutical industry


• Establish best practices, identify the need, and drive the creation of functional standard operating procedures for clinical data management, biostatistics, and statistical programming

• Advanced degree (PhD preferred) in statistics, biostatistics, or related field


• Minimum 10 years of experience in clinical trials


• Must demonstrate familiarity with both early and late-stage drug development - statistical aspects of drug development regulations with regards to design and conduct of clinical trial, and analysis data therefrom


• Must have experience interacting with drug development regulatory agencies (e.g., FDA and/or EMA)


• Experience in antibiotics development preferred.


• Expert level of proficiency with SAS and/or other statistical software platforms.


• Must have excellent project management skills (including management of vendor/CRO outsourced work)


• Must possess strong interpersonal, verbal, and written communication skills


• Must be able to prioritize multiple tasks and goals to ensure timely and within-budget high quality deliverables


• Must work well within multi-disciplinary teams and have proven abilities to coordinate and drive projects in a matrix organization


• Excitement about the vision and mission of Spero, as well as Data Science mission.

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 requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason or genuine religious belief relating to vaccinations. All employees must be in compliance with Spero Therapeutics’ COVID-19 vaccine policy at the commencement of their employment. 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.