Associate Director, Biostatistics

Role Summary

Directs internal and external teams across multifunctional projects, leading initiatives to gather, organize, and analyze data from multiple sources such as virology data, Case Report Forms, and patient tracking. Collaborates with statisticians, programmers, clinical staff, and regulatory and project-management colleagues to meet deliverables and timelines for statistical data analysis and reporting. Oversees technical and operational statistical activities for a group of clinical trials or indications, and leads departmental strategic initiatives. Defends statistical aspects with regulatory agencies and fosters high-performing teams with clear direction.

Responsibilities

• Work collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Works with management and Human Resources to satisfy short-term staffing needs, develops staff capabilities, and recognizes/rewards desired performance.
• Defends statistical aspects with regulatory agencies and examines functional issues from a broader organization perspective.
• Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources.
• Leads two or more components of departmental strategic initiatives.
• Proven ability to determine the functions most critical to company success and to support priorities within functional area.
• Anticipates obstacles and difficulties of clients and acts to meet goals.
• Proven ability to pull together and lead highly effective teams and create a clear sense of direction.

Qualifications

• Required: PhD with 5 years of industry experience OR Masters degree with 8 years of experience or Bachelors degree with 10 years of experience
• Required: Excellent verbal and written communication skills and interpersonal skills
• Preferred: Ability to design and use all available vehicles for effective scientific communication within and outside the company