Associate Director / Director Exploratory Statistics

Summary

Reporting to the Head of Biostatistics, the successful candidate is a highly motivated Biostatistician with proven abilities who will drive activities in support of the exploratory analysis of large and complex data sets from various clinical programs. The AD/Director, exploratory statistics will provide statistical and programming capability in exploratory clinical research by providing strategic input and leadership to analyze all phases of clinical data. Objectives may be to support identifying markers of disease progression and treatment response and for patient selection or stratification in clinical trials.

Responsibilities

• Under the direction of the VP of development strategy and analysis, who will select and prioritize projects, the successful candidate will assume a lead role for providing statistical supports in exploratory clinical research, including providing strategic input and leadership on statistical methods, analysis and interpretation of large and complex data sets from clinical trials in various disease areas and stages, etc.
• Work with other BDM members or consultants to develop effective statistical approaches applicable to the project. Lead the statistical thinking for all aspects of the exploratory analyses, including identification of the scientific questions, development statistical plans, and interpretation and communication of the results
• Guided by projects prioritized by the VP of development strategy and analysis, identify and apply novel analysis/modeling techniques for interpreting clinical and pre-clinical data and enhancing tools for decision making in development programs that span therapeutic areas, from pre-clinical to completed phase 3 clinical trials.
• Develop and maintain good working relationships with clinical scientists, therapeutic biostatisticians, and external collaborators to drive program strategies and decisions. Proactively seek inputs from other experts within and outside the group on various projects and research activities, and share technical information when appropriate.
• Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions. Examples of such tools include SAS, S-Plus, R, etc.
• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization.
• Provide technical direction and mentoring to staff. Maintain awareness of industry standards and regulatory requirements and communicate within team. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation.

Experience And Required Skills :

• 8+ years of related experience with demonstrated skills and accomplishments.
• Working in a changing and busy environment. Exercising judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
• Working independently - self-directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required.
• Demonstrated strong leadership, project management, teamwork, and interpersonal skills.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques.
• Experience with application of technical principles, theories, and concepts to pharmaceutical clinical development and lifecycle management.
• Familiarity and experience with regulatory guidelines for drug development, submissions, and statistical practices.
• Excellent communication, presentations and report writing skills, and the ability to explain complex technical details in ways that can be understood by statisticians and non-statisticians as appropriate to the audience.
• Proven ability to effectively represent Biostatistics in multidisciplinary meetings
• Strong programming and computing skills.

Education:

• Ph.D. in (bio)statistics, and related fields.

Our Client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, their unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in their own laboratories. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.