Executive Director, Biostatistics

About the Company

Innovative pharmaceutical company specializing in metabolic & fatty liver disease therapeutics

Industry
Pharmaceuticals

Type
Privately Held

Founded
2016

Employees
51-200

Categories

• Pharmaceuticals
• Medicine
• Manufacturing
• Chemical Products
• Drug Manufacturing & Research
• Healthcare

About the Role

The Company is seeking an Executive Director of Biostatistics to lead and oversee a range of biostatistical activities across all phases of clinical development. The successful candidate will be responsible for translating R&D objectives into work products, establishing statistical strategies, and ensuring their quality execution. This role involves not only conducting complex statistical analyses and developing Statistical Analysis Plans but also contributing to regulatory documents and coordinating with other biostatisticians and programmers to meet R&D objectives. The Executive Director will also play a key role in contributing to clinical and regulatory strategies, submission documents, and engaging with external scientific and industry forums.Applicants for the Executive Director of Biostatistics position at the company should hold a Ph.D. in statistics or biostatistics and have a minimum of 10 years' experience in the pharma or biotech industry. The role requires a proven track record in supporting NDA regulatory submissions and interacting with health authorities such as the FDA, EMA, and PMDA. Expertise in advanced statistical methods, clinical trial design, and the ability to effectively communicate complex statistical issues to non-statisticians are essential. The ideal candidate will have in-depth knowledge of regulatory guidelines in pharmaceutical development, excellent organizational and communication skills, and the ability to mentor and contribute to the development of more junior staff members.

Hiring Manager Title
Chief Data and Analytics Officer

Travel Percent
Less than 10%

Functions

• CEO/President
• Non-Profit Management
• Operations
• General Management
• Strategy