- Review and guide the statistical design and analysis plan of protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure the statistical analysis plan is methodologically sound and consistent with the objectives of the protocol. Ensure adherence to project and functional standards of data collection and analysis, and implement these standards.
- Collaborate with Data and Statistical Sciences (DSS) and cross-functional stakeholders in developing best practices, standard operating procedures and governance processes for database activities. Ensure consistent implementation of data standards and database structures specific to projects and therapeutic areas. Ensure all database-related DSS activities are executed timely and with high-quality.
- Demonstrate excellent understanding of statistical concepts and methodology. Lead introduction to novel statistical methodological approaches improving 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.
- Ensure that study results & conclusions are scientifically sound, clearly presented, and supported by statistical analyses provided. Prepare oral and written reports to communicate results. Represent DSS on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports & publications. Ensure the accuracy of the statistical component of scientific reports and publications with high quality
- Interact with stakeholders so that statistical methods are consistently well applied. Provide statistical insight in addressing questions. Propose novel solutions to technical issues.
- Act as the liaison for statistical and operational issues on AbbVie collaborative studies with outside universities, investigators, 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.
- Partner with Clinical and Regulatory to create development strategies. Represent DSS on project team(s) to provide DSS input to compound/drug development and ensure alignment with DSS management. Lead communication between assigned project team(s) and DSS to ensure timely communication, proper strategies, and alignment of priorities between project team and DSS management. May represent DSS on data monitoring committees. Build interdepartmental relationships.
- Provide professional leadership, training and mentorship to staff. Develop and supervise seminars, short courses and publications. Gain expertise in innovative statistical methods. Develop front-line managers. Develop and implement recruiting strategy. Plan and manage functional representation and ensure adequate resource allocation (including CROs) for projects. Will manage 2 or more direct reports.
- Plan and coordinate departmental resources to meet therapeutic area priorities. Ensure development programs incorporate sufficient statistical rigor and quality to meet global regulatory requirements. Ensure regulatory submission documents are critically reviewed. Ensure appropriate functional representation at regulatory agency and advisory committee meetings. Ensure all applicable regulatory requirements for work processes are met.
- 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.
Level will be based on education and years of experience.
- MS (with a minimum of 14 years of experience) or PhD (with a minimum of 10 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 14 years (MS) or 10 years (PhD) of experience in pharmaceutical development. Experience in leading NDA, BLA, and or CTD submission preferred (for clinical statistics only). In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues associated with scientific research trials, SOPs, etc.). Experience interacting with regulatory agencies.
- Minimum of 2 years of management experience required for people managers.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic .