Associate Director, Statistics
The Associate Director of Statistics provides scientific and statistical leadership for assigned clinical development projects. A visible and collaborative role that works in partnership with clinical and regulatory experts to advance medicines to our patients.
Major Job Responsibilities
- Protocols: Play a critical role in study design and protocol development to ensure that study designs and analysis approaches 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 the 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.
- 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.
- 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.
- 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.
- MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field
- High degree of technical competence and excellent 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 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
- Pharmaceutical or related industry knowledge required, including direct experience and good understanding of drug development and life-cycle management in a regulated environment.