Careers

Title: Director/Senior Director, Biostatistics

Location: Waltham, MA

About the Company

Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat urgent and serious infections as prioritized by the CDC and WHO.  The innovative and robust pipeline include two late-stage programs against highest-priority pathogens - sulbactam-durlobactam (SUL-DUR) (targeting A. baumannii infections) and zoliflodacin (targeting Neisseria gonorrhoeae).  Three additional programs in early-stage development include ETX0462 against Pseudomonas aeruginosa, ETX0282CPDP against MDR cUTIs, and NBP2 for Gram (-) infections. 

 

Position Summary

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.

 

Responsibilities:

  • 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.

 

Qualifications:

  • 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.

 

Entasis is proud to be named one of the BEST workplaces in HealthCare and Biopharma by the Great Place to Work Institute and Fortune Magazine! https://www.greatplacetowork.com/certified-company/7022538

Entasis offers a comprehensive benefits package to all eligible employees including health, dental, vision, 401(k), Health Savings Account, Employee Assistance Program, Short/Long Term Disability Insurance, and Paid Time Off. 

Entasis is an equal opportunity workplace and participates in E-Verify.  We welcome diversity and are committed to creating an inclusive environment for all employees.   All employment is decided on the basis of qualifications, merit, and business need.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.

Entasis considers the health and safety of it’s employees and community a top priority.  To be employed by Entasis you will be required to be fully vaccinated or to have met the legal criteria for a reasonable accommodation.  If you have any questions or concerns, please discuss them with your recruiter during the application/interview process.

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