Associate Director Biostatistics

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:

The Associate Director of Biostatistics plays a key role in supporting the design, analysis, and interpretation of clinical trials across all phases of drug development. This role works cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and other teams to ensure the successful execution of clinical studies. Incumbents in this role are responsible for ensuring that data analyses are conducted with scientific rigor and compliant with regulatory requirements.

Essential Duties & Responsibilities:

• Provides statistical inputs (e.g., study design, study endpoints, sample size with power calculation, and statistical analysis methodologies) for each study protocol.
• Reviews database design, electronic case report forms (eCRFs), and completes edit checks
• Develops statistical analysis plan (SAP) and table/listing/figure (TLF) shells for each study.
• Reviews and validates analysis datasets and TLFs.
• Reviews CDISC submission data packages, including annotated case report forms (aCRFs), SDTM datasets, ADaM datasets, reviewers' guides, and Define.xml.
• Leads statistical activities related to statistical programming and data management.
• Performs simulations to create mock analyses and proposes new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
• Interprets analysis results and provides statistical inputs to clinical study reports (CSR).
• Performs ad-hoc and/or post-hoc statistical analyses, including the statistical programming, for publications.
• Develops integrated statistical analysis plans (ISAP) for safety and efficacy.
• Reviews and validates TLFs for integrated summaries of safety and efficacy (ISS and ISE).
• Assists in developing and maintaining biostatistics, programming, and data management Standard Operating Procedures (SOPs).
• Participates in communications with regulatory agencies for statistical aspects of study designs and data analyses.
• Other responsibilities and projects as assigned.

Supervisory Responsibilities:

• 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 with a minimum of six years of experience in the pharmaceutical, biotechnology, or Contract research organization industry preferred or Master's degree in Statistics, Biostatistics or other scientific field with a minimum of nine years of experience in the pharmaceutical, biotechnology, or Contract research organization industry.
• Knowledge and understanding of advanced statistical concepts and techniques with experience in adaptive designs, longitudinal data analysis, handling missing data using pattern mixture models, and sensitivity analysis.
• Proficiency in SAS programming (including SAS macro) and familiarity with other statistical packages (e.g., PASS, nQuery, R).
• Familiarity with Food Drug Administration (FDA) guidance related to statistics and statistical programming.
• Familiarity with statistical methodologies that apply to Phase 1 to 4 clinical studies.
• Experienced in NDA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.
• Previous experience in PK, PK/PD methods, and clinical trial simulation a plus.
• Excellent presentation, communication, attention to detail, and management skills.
• Knowledge of ICH/GCP guidelines.
• Excellent interpersonal and communication skills in English language (writing, speaking, comprehending).
• Proficiency in Microsoft Office package including Word, Outlook, and Excel.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• 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 $165,000 to $195,000. 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.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

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