Our client, in the biotechnology / life sciences industry, is seeking a GI Statistics, Senior Manager (contract to hire).

POSITION OBJECTIVES:

• Provide leadership at a compound level on clinical, regulatory, and commercial development strategies
• Promote efficient innovative methodologies and optimal development plan
• Contribute to strategies for statistics related technologies, processes, and standards

POSITION ACCOUNTABILITIES:

• Independently represent the statistics function on global therapeutic areas supporting clinical studies and compound and/or TA-level programs.
• Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across therapeutic areas, including timelines.
• Provide statistical leadership in developing and reviewing the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAs as appropriate.
• Oversee standards of definition and implementation of therapeutic area level database (including derived database), analysis, and reporting standards. Collaborate with Data Management, Programming, Safety Statistics, Clinical, and PV to provide suggestions for achieving high-quality databases and specifications.
• Oversee compound and/or TA-level analysis and reporting activities.
• Identify and interact with external statistical experts for issues related to design, methodology, and results as the primary contact and spokesperson.
• Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management
• Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis techniques, and lead the implementation of innovative approaches within and/or across TAs as appropriate.

EDUCATION, BEHAVIORAL COMPETENCIES, AND SKILLS:

• Ph.D. in statistics or biostatistics with a minimum of 6 years of relevant experience Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures
• Strong collaborative skills and ability to work with a cross-functional team
• Advanced knowledge of clinical study designs, analysis methodology, and data interpretation.
• Advanced knowledge of the pharmaceutical industry, and 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, and analysis of clinical trials and regulatory submissions.
• Excellent oral and written communication skills.