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 h.hennigan@proclinical.com
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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