Senior Manager, Statistics

Senior Manager, Statistics

Irvine, CA

• Function: Research & Development
• Work location type: Hybrid
• Job Type: Full-time
• Job ID: R00151082

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Early Oncology Statistics provides statistical leadership to support the research and development organization for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.

Responsibilities

• Support regulatory submission and product life-cycle management strategy planning and implementation. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation). Work independently to implement sound statistical methodology in scientific investigations.
• Represent the function on project team(s) to provide functional area input to asset development. Lead in identifying scientifically appropriate data collection instruments. Provide programming specifications for derived variables and analysis datasets. Guide Data Science and other functions in preparing for database lock. Ensure accuracy of data released for statistical analysis.
• Independently perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines. Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
• 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.
• Work collaboratively with multifunction teams per agreed timelines. Clearly explain statistical concepts to non-statisticians. Provide responses to questions from clients and pursue analyses suggested by data under supervision.
• Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.
• Lead statistical support for benefit-risk planning and assessment. Partner with cross-functional team to develop output specifications to address both pre-planned safety analyses and ad hoc requests.

Qualifications

• MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly related field

• Oncology experience preferred

• High degree of technical competence and effective 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 manage project timeline and quality of deliverables

• 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 desired, including experience and understanding of drug development and life-cycle management in the regulated environment

• Some experience supporting safety-related projects (eg, ISS, benefit-risk assessment, signal detection) is preferred

• Additional Information

• Travel: Yes, 5% of the Time

• Pay Range: $124,500 - 236,500 USD

• US & Puerto Rico only - to learn more, visit

• Location: Moses Lake

• This role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.