Sr. Manager / Associate Director, Statistics

This role will be required to be on-site 3 days / week in Irvine, CA

This role can be hired at a Sr. Manager or an Associate Director level depending on years of relevant experience; previous work, education, training, and statistics capabilities

Description:

Abbvie is a leading company which offers the largest portfolio of dermal fillers specifically designed for different areas of the face/body to address aesthetic concerns and enhance the quality of life for those who experienced. This position is to lead a medical device project / studies of new generational dermal filler with pivotal studies planned for major regions including USA, and rest of the world targeting multiple indications. 

Experienced statistician who pursuits this opportunity will lead the complete life-cycle management of the new generational filler project including study design considerations based on regulatory agency comments, execution of pivotal trials, assessment of exploratory endpoints and regulatory submission for marketing authorization approvals. Talented statistician who is passionate in the application of statistical methodologies will be able to apply his/her expertise as a strategic partner in a collaborative cross-functional team  including but not limited to Clinical Development (CD), Clinical Development Operations, Clinical Data Strategy and Operations (CDSO), Statistical Programming (SP), Regulatory Affairs (RA), Biological Research, etc. Given unique regulatory requirements for medical device, this project-lead statistician will gain regulatory submission experiences in the near future.

Responsibilities:

• Protocols: Direct development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Assist in developing project and functional standards of data collection and analysis, and implement these standards.
• Database Activities: Collaborate with Data Sciences, Statistical Programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Contribute to data monitoring plans. Develop and implement project-specific data standards. Ensure accuracy and consistency of data released for statistical analysis.
• Statistical Analyses: Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine need for development of novel statistical methodology.
• Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analyses. Prepare oral and written reports to communicate results. Represent Data and Statistical Sciences on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications with high quality.
• External Engagement: Act as the liaison for statistical and operational issues on AbbVie collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures, CROs or licensing activities. Build external scientific contacts which foster professional development and promote the reputation of the department. Work with Director to build relationships between DSS and outside investigators and medical/scientific experts.
• Project Team Involvement: Partner with Clinical and Regulatory to create development strategies for assigned project. Represent department on project team(s) to provide statistical input to compound/drug development and align with functional management. Lead communication between assigned project team(s) and department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional management.
• Training and Supervising: Train and mentor staff on statistical methodology and operations. Participate in department seminars, short courses and presentation of scientific articles. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff. People managers will manage 2 or more direct reports.
• Regulatory Activities: Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to meet SOPs and regulatory requirements.
• Compliance: Compliant with applicable corporate and divisional policies, procedures and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the Statistics function. Ensure compliance with department standards, GxP and best operating practices for staff and self. Complete all assigned training on time.

Qualifications for Associate Director, Statistics:

• MS (with a minimum of 10 years of experience) or PhD (with a minimum of 6 years of experience) in Statistics, Biostatistics, or a highly related field.
• Broad knowledge of, and compentence in, statistical methodology (including experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming) and experience in applied statistics/statistical consulting.
• At least 10 years (MS) or 6 years (PhD) of experience in pharmaceutical development. Understanding of global regulatory requirements. Experience interacting with regulatory agencies highly desirable.
• Management experience highly desirable for people managers.
• Expertise in statistical methodologies such as predictive modeling and inference, machine learning methods, mixed effects models, multivariate analysis, etc.

Qualifications for Sr. Manager, Statistics:

• MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly
  related field.
• 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.
• (SSG) Some experience supporting safety-related projects (eg, ISS, benefit-risk assessment, signal detection)
  is preferred
• (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics,
  statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and
  bias minimization in observational studies preferred.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs. 

This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.