Director Biostatistics

Proclinical Staffing; Boston (MA); On-site; USD 250,000 - 300,000; Full time

Job summary

Proclinical Staffing seeks a Director of Biostatistics to lead late-phase clinical programs in biotechnology. The ideal candidate will mentor statisticians, collaborate across departments, and ensure compliance and innovation in clinical trials focused on rare diseases. This role offers an impactful opportunity in an expanding organization.

Qualifications

• Advanced degrees and experience required to lead biostatistical efforts.
• Experience in clinical development through Phase 3 is necessary.
• Familiarity with CDISC standards is valued.

Responsibilities

• Lead large complex clinical development programs.
• Collaborate with various departments to design trials.
• Ensure compliance with SOPs and departmental standards.

Skills

Communication

Presentation skills

SAS programming

R programming

Basic understanding of biology and RNAi

Knowledge of ICH GCP

Experience in clinical development

Adaptive trial designs

Bayesian analysis

Education

Advanced degree in Statistics or Biostatistics

Job description

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Director Clinical Operations and Biometrics, Global Biometrics SME

Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.

Proclinical is seeking a Director of Biostatistics to lead and manage complex late-phase clinical development programs in the rare disease and biotechnology sector.

Primary Responsibilities:

The successful candidate will be involved representing the Biostatistics team within the broader Data Sciences and Statistics group, mentoring statisticians, and fostering a collaborative work environment. The position requires collaboration with various departments to design innovative clinical trials and contribute to regulatory submissions.

Skills & Requirements:

• Advanced degree in Statistics or Biostatistics or equivalent.
• Strong communication and presentation skills.
• Experience with SAS programming.
• Basic understanding of biology and RNAi.
• Experience in clinical development through Phase 3.
• Knowledge of ICH GCP and industry best practices.
• Proficiency in R programming.
• Familiarity with CDISC standards.
• Experience with regulatory authority interactions.
• Background in drug development for rare genetic diseases.
• Experience with adaptive trial designs and Bayesian analysis.

The Director Biostatistics' responsibilities will be:

• Lead large and complex clinical development programs.
• Represent Biostatistics on the Clinical Development Team.
• Mentor statisticians and promote teamwork and innovation.
• Ensure compliance with SOPs and departmental standards.
• Collaborate with Clinical Development, Regulatory, and Clinical Operations to design trials.
• Write statistical sections of clinical trial protocols.
• Review and approve stratification/randomization schema.
• Prepare statistical analysis plans.
• Provide statistical guidance on ongoing trials.
• Collaborate on trial data analysis and interpretation.
• Contribute to clinical study reports and regulatory documents.
• Lead biostatistics support for regulatory submissions.
• Manage resource planning, allocation, and timeline management.
• Oversee internal and vendor statistical and programming support.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at [e-mail]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Professional Services

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