Senior Director, Biometrics

Enanta Pharmaceuticals; Watertown (MA); On-site; USD 204,000 - 285,000; Full time

Job summary

Enanta Pharmaceuticals is seeking a PhD-level biometrics leader to guide statistics, data science, and programming for our clinical programs. You will shape strategy, mentor teams, and partner with clinical, regulatory, and operations to advance innovations in virology and immunology.

You will oversee budgeting, resource planning, and program governance while ensuring adherence to GCP/ICH guidelines and data standards.

Qualifications

• PhD in statistics/biostatistics with significant biometrics experience in biotech/pharma.
• Proven leadership of Biometrics teams and department strategy.
• Strong budget planning, forecasting, and cross-functional collaboration.
• Deep knowledge of GCP/regulatory requirements (ICH) and data standards.

Responsibilities

• Coordinate biometrics programs delivery in line with budgets and SOPs.
• Provide strategic biometrics input to clinical programs and regulatory teams.
• Lead development and mentorship of Biostatistics and programming staff.
• Represent biometrics in external meetings and regulatory interactions.
• Oversee financial planning, forecasting, and resource allocation for biometrics programs.
• Drive process excellence and adoption of new technologies in biometrics.

Skills

Biostatistics

Cross-functional leadership

Documentation management

Education

PhD in statistics/biostatistics

Job description

Join us in transforming the lives of patients

Are you passionate about making a significant impact in improving patients' lives? At Enanta, we are committed to discovering and developing novel small molecule drugs for indications in virology and immunology. Our collaborative, fast-paced environment empowers every team member to meaningfully contribute to our goal of advancing healthcare and improving patient outcomes.

What You'll Do

• Resource & Delivery Management: Build, oversee and lead delivery of Biometrics programs in line with budgets, operational procedures, regulations, guidelines, and quality standards.
• Regulatory & Compliance: Provide strategic leadership and a clear biometrics voice for Enanta's clinical programs in conjunction with the Clinical Development, Clinical Pharmacology, Clinical Operations and Regulatory; Provide expert input into establishing internal standards, processes and policies for the use of data and the conduct of observational studies.
• Process Excellence: Drive and foster innovation and adoption of emerging technologies/methodologies/approaches within Biometrics in line with long term functional/organizational roadmap and Enanta's SOPs, GCP and ICH guidelines.
• External Partnerships: Engage in strategic communication with executive leadership, cross-functional leadership and external stakeholder networks to optimally influence organizational outcomes.
• Regulatory & Compliance: Act as a key spokesperson and influencer for Enanta's Biometrics at external meetings, including regulatory interactions and scientific meetings; Oversee Biometrics financial planning/forecasting and budget management, timeline development and tracking, and assessing resource needs for respective program(s).
• People Leadership: Lead and mentor Enanta colleagues and contractors. Establish and drive people management processes around performance management, engagement, and development - balancing people aspirations and business needs.

What You Bring

• Education & Experience: PhD in statistics/biostatistics with significant experience in biometrics and statistical analysis in biotech/ pharma industry.
• Leadership Experience: Significant experience leading Biometrics activities and managing Biostats and programming teams in a leadership capacity; Significant experience with development of overall department/area strategy, operational management of plans with cross-functional teams, as well as budget planning & management.
• Stakeholder & Partner Management: Experience and demonstrated success in driving high-quality clinical development programs and developing multi- disciplinary high-performing team/s across multiple levels; Significant experience working with senior leadership team and other external audiences (e.g. KOLs, regulatory bodies).
• Regulatory Knowledge: Expert knowledge of Good Clinical Practice (GCP) and regulatory requirements.

What Sets You Apart

• Biostatistical Skills: Expert-level capability in biostatistical skills, consistent with the expectations of this role.
• Cross-functional Influence: Expert-level capability in cross-functional influence, consistent with the expectations of this role.
• Document Creation and Management: Expert-level capability in document creation and management, consistent with the expectations of this role.

Our Core Values

Curiosity: You demonstrate an unrelenting desire to explore, question, and innovate.

Respectful: You engage with colleagues and partners with professionalism and care.

Empathy: You are compassionate, both in teamwork and when thinking about patient impact.

Agility: You thrive in fast-paced environments and adapt quickly to changing circumstances.

Team-Oriented: You embrace collaboration, understanding that success comes from collective efforts.

Entrepreneurial Spirit: You are proactive, continuously seeking opportunities to improve and grow.

Why Join Us?

At Enanta Pharmaceuticals, you will be part of a team working on projects and programs that truly matter. We offer a supportive, inclusive environment where innovation is not just encouraged but celebrated. You'll have the opportunity to grow, collaborate, and make a tangible impact.

Pay Transparency

Enanta is committed to providing compensation transparency. The expected base salary range for this position is $204,000 to $285,000, based on experience, qualifications, and market conditions. Offers will be determined by several factors, including individual experience and expertise, ensuring both equity and competitiveness.

About Enanta

Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT, STAT6 and MRGPRX2 inhibition.

Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information.

Enanta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.

This is a full time position