Proclinical is currently recruiting for a Director of Biostatistics with a global pharmaceutical company located in Boston, MA. As the Biostatistics Director, you will independently provide strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
- Serve as global statistical lead for assigned therapeutic areas or phase of development or CMC/non-clinical activities.
- Lead and manage team of statisticians supporting cross region studies and programs for identified therapeutic area(s) or phase of development or CMC/non-clinical activities; manages assignments and priorities of team members.
- Develop and mentor staff by utilizing appropriate internal and external resources to achieve short term and long term strategic functional goals.
- Promote innovative clinical trial designs and efficient analysis methodologies
- Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions.
- Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency.
- Leverage standardized analysis methods and reporting standards to maximize global data integrability; identifies best practice for utilization across programs.
- Provide statistical leadership and support for regulatory meetings, submissions and follow up.
- Provide or identify internal and external statistical expertise and capacity to support development activities.
- Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality.
- Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level.
- Provide input for planning and management of external budgets related to statistical deliverables.
- Participate/Leads in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in the company.
Skills and Requirements:
- PhD in statistics or biostatistics with at least 7 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with at least 10 years of relevant pharmaceutical industry experience
- Experience with at least two NDA/CTDs or other regulatory submissions.
- Experience representing Statistics function in interactions with regulatory agencies.
- Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
- Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
- Strong statistical programming skills
- Excellent oral and written communications skills.
- Specialized statistical expertise in multiple therapeutic areas or development phases.
- Strong inter-personal and people management skills.
- Strong project management skills.
- Strong collaborative skills and ability to work with a cross-functional team.
- Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries.
If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or firstname.lastname@example.org.
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.