Job Summary: To 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.
Essential Duties & 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'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.
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.
Compensation:At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $257,000 to $294,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
