AbbVie Director, Early Oncology Statistics in Redwood City, California
Director, Early Oncology Statistics
USA, California, Redwood City
Research & Development
The Director, Early Oncology Statistics provides scientific and statistical leadership for assigned clinical development projects. A visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.
Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission as appropriate in early-stage clinical development.
Direct or provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Lead the development of protocols, statistical analysis plans, and statistical programming plan.
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety) to create development strategies for assigned projects. May represent function/department on data monitoring committees. Build interdepartmental relationships.
Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research.
Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department.
Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. May represent function/department in discussions with regulatory agencies. Validate external statistical software to meet SOPs and regulatory requirements.
MS (with 12+ years of experience) or PhD (with 8+ years of experience) in Statistics, Biostatistics, or a highly related field
High degree of technical competence and excellent communication skills, both oral and written
Should have Therapeutic Area experience in Oncology for minimum of 2 years
Experience in early-stage clinical development (Phase 1-2) is highly preferred
Experience in direct managing or supervising staff for minimum of 2 years
Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
Significant Work Activities and Conditions: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Job Level Code: D