Our client, in the biotechnology / life sciences industry, is seeking an Associate Director, Statistics (contract to hire).

POSITION ACCOUNTABILITIES:

• Serve as global statistical lead for biomarker development in Oncology Cell Therapy and TA. Provide statistical leadership and support for internal decision making, regulatory meetings, submissions, and follow-up.
• Review key program documents and presentations (portfolio entry document, PRC narratives, biomarker strategy plan), attend Translational Research meetings to develop a comprehensive overview of the existing data in pre-clinical and translational studies, form a deep understanding of the development rationale and strategy, and the key questions that need to be answered from biomarker data, and help the teams identify any statistical shortfalls and propose solutions to overcome them
• Attend scientific conferences (AACR, ASCO, SITC) and stay abreast with the latest developments in IO and cell therapy space with an eye toward acquiring biomarker data that can help augment internal data
• Play a leadership role in the development of Exploratory Analysis Plans and completion of major statistics deliverables and milestones in collaboration with other functions
• Stay up-to-date on emerging technologies and associated data analytic techniques, external databases, and novel methodologies that can help derive the maximum value out of the biomarker data

• Drive/participate in the 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 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.
• Active participation in external professional initiatives and organizations to identify industry best practices and their applicability.

EDUCATION, BEHAVIORAL COMPETENCIES, AND SKILLS:

• Ph.D. in statistics/biostatistics or in bioinformatics with an emphasis on statistics with at least 6 years of relevant industry experience or MS in statistics with at least 10 years of relevant industry experience
• Teamwork is critical for this role. The candidate will be expected to interface with other quantitative functions in the industry routinely and must have strong interpersonal and people management skills, and the ability to influence others, without direct hierarchical authority, to affect change across organizational boundaries.
• Expert knowledge across broad areas of statistical methodologies including subgroup analysis, longitudinal data analysis, multivariate methods, predictive modeling, machine learning, and Bayesian modeling. Strong background in statistical modeling in R or SAS with the ability to independently code relevant programs.
• Expert knowledge of statistical approaches for assays, and biomarker development and validation.
• Advanced knowledge of the pharmaceutical industry, and overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
• Excellent oral and written communication skills.
• Strong project management skills.
• Knowledge of IO Biology and experience working with raw data from emerging biomarker technology platforms in the space (CyToF, TCRSeq, Multiplexed IHC) is a plus