Supernus Pharmaceuticals, Inc. · 12 hours ago
Senior Director, Biostatistics
Rockville, MD
Full-time
Onsite
Director/Executive
$240K/yr - $287K/yr
10+ years expSupernus Pharmaceuticals is an award-winning biopharmaceutical company with over 30 years of experience in developing products for central nervous system diseases. The Senior Director, Biostatistics will lead statistical support and management for clinical trials, ensuring the integrity of the statistical content throughout all phases of development.
BiotechnologyHealth CarePharmaceutical
No H1B
Responsibilities
Provides statistical support and expertise for all necessary activities in Development, specifically design of Phase 1-4 studies and programs
Provides for the statistical content of clinical trials
Provides team leadership for regulatory filings including integrated components
Provides hand-on supports to all statistical deliverables
Provides statistical leadership and insight to team as a senior member of the Clinical Development organization
Interacts with FDA and other regulatory agencies in statistical aspects of study design and data analysis
Works under limited supervision
Assists with other duties as needed by the management
Builds statistical group (including the hiring of new staff and development of existing staff) in an efficient manner to accomplish corporate objectives and elevate overall statistical group’s performance
Leads and/or manages both in-house and CRO activities related to application of statistics to clinical trials data
Leads in the development and review of SOPs related to statistics
Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives
Understands Company Policy and procedure to be able to guide direct reports appropriately
Qualification
Required
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
Experience with PK and PK/PD methods and clinical trial simulation a plus
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
Capable of performing other duties as assigned by Management
Authorized to legally work in the United States without visa sponsorship
Preferred
Experience with PK and PK/PD methods and clinical trial simulation a plus
Benefits
The opportunity to participate in employee stock purchase programs
Performance-based bonus programs
Company
Supernus Pharmaceuticals, Inc.
We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$689.5MKey Investors
UBSNew Enterprise Associates
2023-02-14Post Ipo Debt· $150M
2018-03-13Post Ipo Debt· $350M
2013-04-24Post Ipo Debt· $90M
Leadership Team
J
Jack A. Khattar
President & CEO
F
Frank Mottola
Chief Technical Operations Officer
Recent News
2025-12-08
Supernus Pharmaceuticals, Inc.
2025-12-04
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