Associate Director, Biostatistics

Proclinical is seeking an Associate Director, Biostatistics for a cutting-edge biotech company located in Boston, MA.

Must be eligible to work in the US.

Job Responsibilities:

• Represent Statistics in cross-functional project and study teams in multiple projects
• Provide statistical input into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
• Perform sample size calculations, develop statistical analysis plans and lead TLF development
• Perform statistical analyses and validate analysis results
• Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
• Develop, implement and improve statistical processes and standards
• Support and participate in the development of departmental strategies
• Interact with global regulatory authorities

Skills and Requirements:

• PhD or Masters in Statistics or Biostatistics
• 6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience
• Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH, FDA, EMA) and statistical software like SAS, EAST, and R
• Awareness of the bigger picture, strong orientation to quality, innovative and solution orientated thinking
• Preferred experience with clinical study designs in Oncology or Infectious Diseases

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or p.bonilla@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-PB2