Senior Director, Biostatistics

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 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.

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.
• Familiarity with SAS programming (including SAS macro) and 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.
• Ability 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.

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

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.