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 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.

Below is a list of 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 CDSO, SP,  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 methodologies. 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 Clinical Biostatistics 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 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 the Therapeutic Area (TA) Lead and TA Head to build relationships between DSS and outside investigators and medical/scientific experts.
• Project Team Involvement: Partner with CD and RA to create development strategies for assigned projects. Represent department on project team(s) to provide statistical input to dermal filler 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
• 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

• 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 competence 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.

Applicable to California Applicants Only 

· The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.

This range may be modified in the future. 

· The salary range is (minimum: $ 126,500 to maximum: $ 247,000 ) 

· This job is eligible to participate in our short-term incentive program 

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

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

• • 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 discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.