Job Summary: The Senior Biostatistician will be responsible for trial designs, data analyses and study result interpretation of clinical studies. Under the supervision of a senior staff from the Biostatistics group, the incumbent will work closely with colleagues from Data Management, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

Essential Duties & Responsibilities:

• Participates in clinical trial designs.
• Writes statistical sections of clinical study protocols.
• Reviews case report form (CRF) designs.
• Reviews data management plans (DMPs) and edit checks.
• Develops statistical analysis plans (SAPs), including statistical methodologies, data definitions and tables/listings/figures (TLFs) mock shells for clinical study reports (CSRs).
• Reviews programming specifications and derived datasets.
• Performs statistical analyses and interprets results of these analyses.
• Verifies statistical analysis programs written by other biostatisticians and/or statistical programmers.
• Prepares statistical sections of CSRs.
• Be responsible for the accuracy and completeness of analyses conducted for assigned studies.
• Interacts with staff from other cross-functional groups (e.g., Data Management, Statistical Programming, Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs).
• Participates in the development and validation of CDISC (SDTM & ADaM) datasets and submission packages.
• Other duties as assigned.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• PhD in Statistics, Biostatistics or other related field with at least 1 year of experience in the pharmaceutical/Biotech/CRO industry OR Master's degree with at least 4 years of experience.
• Proficiency in SAS and other relevant statistical procedures/software (e.g., R, nQuery, PASS, ...).
• Excellent verbal communications and written/presentation skills.
• Therapeutical knowledge of psychiatry and/or neuroscience is desired.
• Advanced knowledge of adaptive designs and/or Bayesian analysis techniques is desired.

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 but 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.

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.