Associate Director, Biostatistics
About The Position
With increasing independence, you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development. The Associate Biostatistics Director is responsible for leading biostatistics activities on clinical studies and other projects. Key responsibilities include:
Requirements
- PhD with 6+ years of biostatistics experience is preferred.
- MS in biostatistics or related discipline with 8+ years of relevant experience in statistical analysis of biomedical data using SAS software.
- Minimum of 2 years of cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry, including multiple years of experience managing project teams.
- Significant biomedical statistical analysis experience and proficiency with relevant software and tools.
- Experience developing software and tools to support statistical analysis of biomedical or related data.
- Proven effectiveness in managing projects and teams.
- Advanced knowledge of biomedical statistical analysis, biostatistics best practices, and tools, with demonstrated ability to apply these to improve results.
- Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes.
- Understanding of drug development phases, clinical trials, FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
- Strong communication and organizational skills, and ability to travel when needed
Responsibilities
- Acting as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions by collaborating with other biostatistics team members and cross-functional partners.
- Providing statistical consultation on trial design and study endpoints, authoring statistical analysis plans, and leading projects of increasing complexity or size.
- Overseeing and contributing to the completion of technical and operational statistical activities for groups of clinical trials, and directing teams in the definition, execution, and completion of statistical activities for molecules or marketed products.
- Participating in cross-functional clinical development planning and protocol design discussions to provide biostatistical input.
- Advising partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results.
- Leading the gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products.
- Reviewing and analyzing safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
- Using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development.
- Planning and documenting computer data file structures, development: Message, programming, managing, and maintaining complex statistical databases, and performing or supervising data entry.
- Developing enhancements to statistical software and maintaining knowledge of current and emerging trends in statistical analysis methodologies and tools.
- Providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation.
- Participating in or leading special projects that benefit multiple team members, such as new methodologies, processes, technology, and tools, and contributing to the development and implementation of SOPs and related documentation.
- Providing matrix management to supported projects and independently defining required resources for assigned work.
- Adhering to regulatory requirements, statistical analysis principles, industry standards, and company SOPs.
Benefits
- This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Chemical Manufacturing
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
