Senior Director, Biostatistics
$257,000–$294,000 year
HybridRockville, Maryland, United States
Job Summary
Design Phase 1-4 study programs and provide statistical direction for clinical trial content, including adaptive designs, longitudinal analysis, and PK/PD methods. Lead regulatory filings and interact with FDA on statistical aspects of study design and data analysis. Manage in-house and CRO activities, build the statistical team through hiring and development, and oversee SOP creation and review. Deliver hand-on support for all statistical deliverables and guide direct reports on company policies. Requires 10+ years in pharma, SAS proficiency, and major NDA filing experience. Works under limited supervision in a sedentary environment.
Required Qualifications
- PhD (or equivalent) in Statistics or Biostatistics
- Excellent presentation, communication and management skills with attention to detail and accuracy
- 10+ years of pharmaceutical industry experience (6+ years in a pharmaceutical company or regulatory agency)
- Major participation as the statistical lead in at least 1 NDA filing
- Proven ability to help design successful clinical trials
- Proven ability to independently develop and lead statistical components of several ongoing projects in Phase 1-4
- Proven ability to lead adaptive design, longitudinal data analysis, missing data handling and sensitivity analysis
- Fluent in SAS programming (including SAS macro) and familiarity with other statistical packages (e.g., PASS, nQuery Advisor, R)
- Expert knowledge of FDA guidance related to statistics and statistical programming
- Knowledge of ICH/GCP rules and regulations
- Must be able to clearly articulate project needs and status to project team and upper management
- Excellent interpersonal and communication skills in English language (writing, speaking, comprehending)
- Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF
- Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality
- Ability to lead and manage direct reports and statistical group
- Ability of having an innovative and dynamic approach to work
- A self-starter able to work independently and also comfortable working in a team environment
- Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others
- Authorized to legally work in the United States without visa sponsorship
- Exerting up to 10 pounds of force occasionally and/or carrying objects
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
Desired Qualifications
- Experience with PK and PK/PD methods and clinical trial simulation a plus
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