Location: all cities,NJ, USA
Associate Director Biostatistics
Remote
Contact: Susan Devine - ...@penfieldsearch.com
Our client is a clinical-stage biotech company with an established track record and a strong pipeline in Gene Therapy/Rare Disease, looking for an experienced Biostatistician. This is a hands-on role that will utilize your extensive technical expertise and experience to provide recommendations on statistical issues, design and conduct of clinical trials of all phases. You will develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. This is a collaborative role in which you will interact heavily with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials. Use your broad expertise and unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways and to stay up-to-date with new approaches.
Please have:
• PhD in Statistics/Biostatistics with at least 7 years of relevant pharmaceutical experience
• Knowledge of pharmaceutical environment and regulatory requirements
• Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research
• Excellent project management, interpersonal and communication skills
• Experience with NDAs, and MAA's is highly desired
• Ability to influence and to contribute to the advancement of innovative statistical methodology