Senior Director, Biostatistics

Supernus Pharmaceuticals; Rockville (MD); On-site; USD 257,000 - 294,000; Full time

Benefits offered by this job

Health insurance

401(k) company match

Paid time off

Job summary

Supernus Pharmaceuticals is seeking a Senior Biostatistician in Rockville, MD to lead statistical content for clinical trials from Phase 1 to 4. The ideal candidate will have over 10 years of pharmaceutical experience, including leading regulatory submissions.

Proficiency in SAS programming is essential, alongside a PhD in Statistics or Biostatistics. The role offers a competitive compensation package, including various benefits, within a supportive and innovative environment.

Qualifications

• 10+ years of experience in pharmaceutical industry.
• Major participation in at least 1 NDA filing.
• Experience with PK and PK/PD methods.

Responsibilities

• Provide statistical support for Phase 1-4 studies.
• Lead team for regulatory filings.
• Develop and review SOPs related to statistics.

Skills

Statistical leadership

SAS programming

Clinical trial design

FDA guidance knowledge

Education

PhD in Statistics or Biostatistics

Tools

SAS

Microsoft Office

Job description

Supernus Pharmaceuticals is an award‑winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

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, 401(k) 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.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.