Director, Statistics

AbbVie•South San Francisco, CA

20h

About The Position

The Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. This is a visible and collaborative role, working in partnership with clinical and regulatory experts to advance medicines to patients. The Director leads statistical support for one or more clinical development projects, develops statistical strategy for project development and regulatory submission, and directs or provides statistical leadership for design, analysis, and reporting for clinical or other scientific research programs. The role involves leading the development of protocols, statistical analysis plans, and statistical programming plans, and representing the function on project teams to provide statistical input and ensure alignment. The Director partners with other functions like Clinical, Regulatory, Patient Safety, or GMA to create development strategies, may represent DSS on data monitoring committees, and builds interdepartmental relationships. The position requires an extensive understanding of statistical concepts and methodology, proposing novel statistical approaches, and ensuring appropriate conduct of analyses. It also involves guiding database-related activities, training and mentoring staff, gaining expertise in innovative statistical methods, assisting in recruiting and professional development, and developing strategies for data presentation and inference. Collaboration in scientific research publication, ensuring accuracy of reports, acting as a liaison for statistical issues with external partners, and building external scientific connections are also key. The Director ensures all applicable regulatory requirements are met, critically reviews regulatory submission documents, and may represent DSS in discussions with regulatory agencies. Validation of external statistical software is also part of the role.

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.
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.

Responsibilities

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.
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, or GMA) to create development strategies for assigned projects.
May represent DSS 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.
Provide sufficient detail to allow programming implementation.
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.
Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
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 DSS in discussions with regulatory agencies.
Validate external statistical software to meet SOPs and regulatory requirements.