Director Biostatistics

Contact: Mark Maurer – mmaurer@penfieldsearch.com

No 3rd party agencies

Job Description: The Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a product line through the entire development process. This role provides statistical input into the drug development plan, research, and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads and contributes to statistical innovation activities.

Responsibilities:

• Lead one or several indications corresponding to one or several compounds in development.
• Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of clinical development plans, studies, submission activities and regulatory interactions.
• Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.
• Lead or contribute to statistical innovation activities including innovative design, advanced analytics, data visualization and template development.
• Independently undertake new and highly complex issues requiring advanced analytical thought
• Foster productive collaboration across Biometrics and cross-functionally, while effectively communicating with key stakeholders.
• Lead and contribute to departmental projects.
• Provide technical guidance and mentoring to Junior statisticians.

Requirements:

• A Ph.D/MS. in Statistics or Biostatistics with more than 10 years of pharmaceutical experience
• Strong knowledge of pharmaceutical environment and broad experience with multi-phase development.
• Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applicable to Clinical Research
• Strong project management, interpersonal and communication skills
• A track record of successful contribution to submission dossiers (IND, CTD) and interactions with regulatory agencies or other external stakeholders
• Experience with NDAs, and MAA’s is highly desired.
• Ability to influence and to contribute to the advancement of innovative statistical methodology.