Associate Director, Exploratory Statistics (Hybrid)

Role Summary

The Associate Director of Exploratory Statistics provides statistical leadership in drug discovery and non-clinical and clinical biomarker activities to support target identification/verification, characterization of patient subgroups or markers of disease progression and treatment response, and patient selection or stratification to advance precision medicine.

The role collaborates with discovery researchers, translational scientists, and clinicians in the design, collection, analysis, and reporting of multi-dimensional biomarker data from discovery to late-stage clinical development to enable objective decision-making for each clinical program in the responsible therapeutic area.

This is a hybrid on-site position. Candidates must be local to San Francisco, CA or Lake County, IL.

Responsibilities

• Lead statistical support for clinical biomarker programs through own efforts or those of the team. Provide expertise/Lead statistical strategies in one or more therapeutic areas for Discovery, Translational Science and Biomarker projects to advance precision medicine.
• Train and mentor staff on statistical methodology and scientific interpretations. May supervise contract statisticians or junior statisticians. Develop strategy for building data analysis pipelines, statistical evaluation and interpretation of large and complex data sets in various stages of the responsible therapeutic areas. Identify and implement effective data analysis, computational or modeling techniques for interpreting discovery and biomarker data.
• Plan and track project activities, timelines, and resource utilization. Drive for timely and high-quality deliverables. Assist in recruiting qualified personnel and arranging training opportunities for professional development of staff.
• Maintain awareness of advanced exploratory statistical analysis technology, industry practices/standards and regulatory requirements and communicate within and outside team.
• Providing leadership in designing, analyzing and reporting of biomarker-based clinical trials or other scientific research studies. Independently developing or providing guidance to develop biomarker section of clinical trial protocols or biomarker analysis plans. Work independently or provide guidance to implement sound statistical methodology in scientific investigations.
• Represent function/department on project team(s) to provide statistical input to biomarker discovery/development and drive alignment with functional management. Partner with other functions to create strategies for assigned projects.
• Maintain an external presence within the statistics community by representing AbbVie on advanced and emerging topics. Attend key conferences and workshops in support of the presentation of company data, and the evaluation of scientific data presented across industry and academia.

Qualifications

• PhD in statistics or related field with 6+ years of experience or Master in statistics or related field with 10+ years of experience in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in advanced statistical/quantitative methods (e.g., adaptive designs, Bayesian methods, optimization, machine learning, modeling, multiplicity, subgroup identification, precision medicine, etc.).
• Able to build strong relationships with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
• Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.