Title: Director/Senior Director, Biostatistics
Location: Waltham, MA
About the Company
Entasis Therapeutics (Nasdaq:ETTX) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including SUL-DUR (targeting A. baumannii infections) being evaluated in a Phase 3 registration clinical trial, zoliflodacin (targeting Neisseria gonorrhoeae) being evaluated in a Phase 3 registration clinical trial, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).
The Director/Senior Director of Biostatistics will be involved in the strategic plan, design, execution, analysis, and reporting clinical studies across Entasis’ development programs that are leveraging a unique pathogen-targeted approach to address the critical threat of serious multidrug-resistant Gram-negative infections.
- Develop biostatistics strategy on clinical development plans, integrated safety data analysis across portfolio, and key components of regulatory submissions.
- Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining clinical study strategies and delivering results with high quality and on time.
- Leader in bringing innovative statistical thinking and methods to help drive applications of statistical methods that enhance the probability of successes for clinical development programs.
- Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types.
- Oversee development of statistical sections of clinical study protocols, statistical analysis plans, review and contribution to clinical study reports, regulatory submission materials, on and key specifications for statistical programming implementation of analyses.
- Interact with regulatory agencies, and effectively address the statistical questions and requests.
- Represents Biostatistics at executive meetings, advisory board meetings, meetings with key KOLs and advisory committee meetings.
- Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals.
- In addition, will take on items beyond formal job responsibilities.
- PhD with 10+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 12+ years of relevant experience.
- Substantial past regulatory experiences, including interactions with FDA, EMA, and NDA/MAA submission experiences. Antibiotic/Anti-infective NDA/MAA submission and approval experience preferred.
- Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
- Operational excellence mindset with ability to develop innovative/creative. statistical/technical solutions to complex scientific and clinical problems.
- Broad knowledge of medical/biological terminology and clinical trial design in the antibiotic space.
- Ability to explain methodology and consequences of decisions in lay terms.
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience working with and overseeing CROs, vendors, and relationship management preferred.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.