Associate Director, Biostatistics

Clinical Dynamix, Inc.; Burlington (MA); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

Clinical Dynamix, Inc. seeks an Associate Director, Biostatistics to lead statistical strategies for oncology programs. You will design trials, develop SAPs, and partner with clinical, data management, and regulatory teams to ensure robust analyses and regulatory readiness.

You will mentor statisticians, oversee SDTM/ADaM outputs, and contribute to NDA/MAA submissions in a fast-paced, collaborative environment in Burlington, MA.

Qualifikationen

• PhD in Biostatistics or related field with 5+ years of industry experience, or MS with 7+ years.
• Experience in oncology drug development preferred.
• Strong knowledge of FDA, EMA, and ICH guidelines, and a solid understanding of the end-to-end drug development process.
• Expertise in statistical methods for clinical trials and ability to communicate complex concepts clearly.

Aufgaben

• Serve as the lead statistician for clinical trials, contributing to efficient study design and rigorous data analysis.
• Provide high-quality statistical support across clinical programs, ensuring scientific robustness and alignment with development goals.
• Design and refine clinical trial methodologies; author study synopses and protocols.
• Collaborate with data management on CRF design and database quality to ensure reliable datasets.
• Develop statistical analysis plans and ensure clear, transparent documentation.
• Guide and mentor statistical programmers in creating SDTM/ADaM specifications, datasets, and statistical outputs.
• Review and approve statistical deliverables to ensure consistency, accuracy, and regulatory readiness.
• Interpret study results and contribute to clinical reports, presentations, publications, and regulatory documentation.
• Author statistical content for regulatory submissions and support interactions with global health authorities.
• Monitor timelines, deliverables, and support resource planning to keep programs on track.
• Participate in vendor selection and provide oversight to ensure high-quality, timely statistical outputs.
• Contribute to the development and evolution of Biostatistics processes, standards, and best practices at Company.
• Communicate proactively, collaborate effectively, and maintain a solutions-oriented approach in a dynamic, fast-paced environment.
• Demonstrate ownership, accountability, and a commitment to delivering high-quality work.
• Provide constructive feedback to support team development and shared success.

Kenntnisse

Oncology drug development experience

Regulatory knowledge (FDA/EMA/ICH)

Communication & leadership

Cross-functional collaboration

Problem solving

Project management

Ausbildung

PhD in Biostatistics or related field

MS in Biostatistics (7+ years experience)

Tools

SAS

R

CDISC SDTM/ADaM

Regulatory submissions (NDAs/MAAs)

Jobbeschreibung

Associate Director, Biostatistics Job Description

Position Summary

The Associate Director, Biostatistics is responsible for partnering with clinical, regulatory, data

management and statistical programming teams to deliver robust statistical methodologies that

advance clinical program objectives and ensure compliance with industry standards. This

individual will contribute to the success of the team and organization by delivering on role-

specific responsibilities while upholding our core working behaviors of Trust and Respect,

Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and

Enablement.

Key Responsibilities

• Serve as the lead statistician for clinical trials, contributing to efficient study design and rigorous data analysis.
• Provide high-quality statistical support across clinical programs, ensuring scientific robustness and alignment with development goals.
• Design and refine clinical trial methodologies; author study synopses and protocols.
• Collaborate with data management on CRF design and database quality to ensure reliable datasets.
• Develop statistical analysis plans and ensure clear, transparent documentation.
• Guide and mentor statistical programmers in creating SDTM/ADaM specifications, datasets, and statistical outputs.
• Review and approve statistical deliverables to ensure consistency, accuracy, and regulatory readiness.
• Interpret study results and contribute to clinical reports, presentations, publications, and regulatory documentation.
• Author statistical content for regulatory submissions and support interactions with global health authorities.
• Monitor timelines, deliverables, and support resource planning to keep programs on track.
• Participate in vendor selection and provide oversight to ensure high-quality, timely statistical outputs.
• Contribute to the development and evolution of Biostatistics processes, standards, and best practices at Company.
• Communicate proactively, collaborate effectively, and maintain a solutions-oriented approach in a dynamic, fast-paced environment.
• Demonstrate ownership, accountability, and a commitment to delivering high-quality work.
• Provide constructive feedback to support team development and shared success.

Skills and Qualifications

• PhD in Biostatistics or related field with 5+ years of industry experience, or MS with 7+ years.
• Experience in oncology drug development preferred.
• Strong knowledge of FDA, EMA, and ICH guidelines, and a solid understanding of the end-to-end drug development process.
• Expertise in statistical methods for clinical trials, up to date knowledge of statistical applications and the ability to communicate complex concepts clearly to diverse audiences.
• Proficiency in SAS and R, and familiarity with CDISC SDTM and ADaM standards.
• Experience contributing to NDAs, MAAs, or other global regulatory submissions.
• Ability to collaborate effectively with CRO partners and manage outsourced statistical activities.
• Strong interpersonal and communication skills, with the ability to build trust and guide cross-functional decision-making.
• Demonstrated accountability, strong analytical thinking, and a data-driven approach to problem-solving.
• Ability to work both independently and within a collaborative, matrixed team environment.
• Sense of urgency, initiative, and adaptability in a fast-moving, small-company setting.
• Excellent organizational, time management, and project leadership skills.
• High attention to detail and strong problem-solving capabilities.
• Willingness to learn, grow, and contribute to Company’s mission.

Working Behaviors (Core Expectations)

• Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
• Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
• Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
• Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
• Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.