Director, Biostatistics
$235,000—$300,000
Apply (opens in a new tab)Director, Biostatistics
Posted 35 days ago
SENIORITY
Manager
SALARY
$235,000—$300,000
About the role
- (including, but not limited to):Familiar with authority guidance documents such as ICH E8, E9, and E9 (R1)
- Provide leadership, guidance, and strategic input as the lead statistician on one or more projects
- Accountable for statistical aspects of clinical development plans, studies and submission activities
- Participate in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents including ICH/FDA E9 (R1)
- PhD in statistics/biostatistics with minimum of 8 year of experience in pharma/biotech
- Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data presentation and interpretation practices
- Strong statistical research ability for statistical methodology
- Experience with IND, NDAs, MAAs and other regulatory submissions a plus
- Ability to work effectively in a cross-functional environment
- Strong statistical programming skills using SAS, R and other relevant software
- Experience with clinical research preferred
- Good communication and interpersonal skills
- Strong project management and communication skills
- Excellent knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
- Excellent knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
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Two examples you can talk through
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A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
