- Leads large and/or complex late phase clinical development program. Represents Biostatistics and the broader Data Sciences and Statistics team including Data Management and Statistical Programming on the Clinical Development Team.
- Mentor statisticians working on the program. Promote teamwork, quality, and innovation through leadership of Data Sciences and Statistics program team meetings. Create a productive work environment. Ensure program team compliance with SOPs and departmental standards.
- Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials
- Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
- Reviews and approves stratification/randomization schema
- Prepares statistical analysis plans
- Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs
- Provides statistical guidance on conduct of ongoing trials
- Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADaM and ad hoc analysis specifications
- Interprets and communicates the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts
- Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
- Leads biostatistics support for worldwide regulatory submissions
- Represents CLIENT in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
- Contributes to scientific articles, summarizing data collected in CLIENT trials
- Consults with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial colleagues on statistical questions in their work
- Leads and/or assists in development of SOPs
- Exercises leadership within Biostatistics, as well as the broader Data Science and Statistics Expertise Area
- Responsible for resource planning/allocation and timeline management across their clinical development program, and recruiting, retaining, managing, and mentoring biostatisticians
- Manages internal and vendor statistical and programming support.
- Ph.D. in Statistics or Biostatistics or Equivalent with at least 8-10 years pharmaceutical statistics experience (preferred), or Masters in Statistics or Biostatistics or Equivalent with at least 10-12 years pharmaceutical statistics experience
- At least 2 years as a people manager, including authorship of performance evaluations
- Excellent written and oral communication and presentation skills
- Experience in clinical development through Phase 3 (NDA submission).
- Understanding of ICH GCP as well as general knowledge of industry best practices and standards
- Proficiency in R programming language
- Experience with CDISC, including SDTM, ADaM, CDASH
- Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities
- Experience in drug development for rare genetic diseases
- Experience with DMPK endpoints and analyses
- Experience designing and conducting adaptive trials
- Experience with Bayesian and/or adaptive clinical trial design and analysis
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Director Biostatistics - Boston, United States - Green Key Resources
Description
Job Description
Job DescriptionThe Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions. The Director reports to one of two Senior Directors of Statistics.
Summary of Key Responsibilities
Qualifications
