Director Biostatistics

Proclinical Staffing; Boston (MA); On-site; USD 130,000 - 180,000; Full time

Job summary

A leading life sciences recruiter seeks a Director of Biostatistics to join a biotechnology company in Boston. The role involves leading clinical development programs in the rare disease sector and mentoring a team of statisticians. Candidates must possess an advanced degree in Statistics or Biostatistics and have experience in drug development, including interactions with regulatory authorities.

Qualifications

• Advanced degree in Statistics or Biostatistics or equivalent.
• Experience in clinical development through Phase 3.
• Knowledge of ICH GCP and industry best practices.

Responsibilities

• Lead large and complex clinical development programs.
• Mentor statisticians and promote teamwork and innovation.
• Collaborate with Clinical Development to design trials.

Skills

Communication

Presentation

SAS programming

Biology knowledge

R programming

Regulatory authority interaction

Adaptive trial designs

Education

Advanced degree in Statistics or Biostatistics

Tools

SAS

R

Job description

Director Biostatistics - Permanent - Boston, MA

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.
• Consult on statistical questions across various departments.
• 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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