Key Responsibilities Includes:
- Protocols: Directs the 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. Develop 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. Guide development and implementation of project-specific data standards. Guide and ensure timely execution of all database-related DSS activities for project.
- Statistical Analyses: Demonstrate excellent understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvements 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.
- Consultation: Interact with stakeholders so that appropriate statistical methods are adequately and consistently applied in deliverables. Provide statistical insight in addressing questions. Propose novel solutions to technical issues. Independently pursue analyses suggested by data, including the pursuit of statistical knowledge needed.
- 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, temporary staff or licensing activities. Build external scientific contacts which foster professional development and promote the reputation of the department. Works with Director to build relationships between department and outside investigators and medical/scientific exp
- Project Team Involvement: Partner with Clinical and Regulatory to create development strategies. Represent DSS on project team(s) to provide statistical input to compound/drug development and align with DSS management. Lead communication between assigned project team(s) and DSS to ensure timely communication, proper strategies, and alignment of decisions/priorities between project team and DSS management. May represent DSS on data monitoring committees. Build interdepartmental relationships.
- Training and Supervising: Train and mentor staff on statistical methodology and operations. Develop and supervise seminars, short courses and publications. Gain expertise in innovative statistical methods. Along with functional leaders, manage statistical resources (Including CROs) to meet project priorities. Recruit qualified personnel and arrange training for professional development of staff. People managers will manage 2 or more direct reports.
- Regulatory Activities: Work with Director to ensure that development programs incorporate sufficient statistical rigor and quality to meet global regulatory requirements. Critically review regulatory submission documents. Ensure appropriate functional representation at regulatory agency and advisory committee meetings. Ensure all applicable regulatory requirements for work processes are met. Ensure validation of 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.
- MS (with a minimum of 12 years of experience) or PhD (with a minimum of 8 years of experience) in Statistics, Biostatistics, or a highly related field.
- Excellent English communication skills, both oral and written.
- Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
- At least 12 years (MS) or 8 years (PhD) of experience in pharmaceutical development. Experience in leading NDA, BLA, and or CTD submission preferred (for clinical statistics only). Understanding of and global regulatory requirements. Experience interacting with regulatory agencies highly desirable.
- Management experience required for people managers.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled