Senior Director, Biostatistics

Role Summary

Senior Director, Biostatistics will contribute to the Company’s Clinical program by providing direction, insight, and hands-on management & leadership covering the statistical content and requirements for Phase 1 through 4 activities.

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.

Supervisory Responsibilities

• 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‚Äôs 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.

Knowledge & Other 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.
• 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.

Other Characteristics

• 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.

Physical Requirements/Work Environment/Travel Requirements

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• 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.
• The worker is not substantially exposed to adverse environmental conditions.