Job Description

The Director, Safety Statistics provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role, the Director works in partnership with patient safety, clinical, and regulatory experts to advance medicines to our patients.

Responsibilities:

Lead the PST statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop safety statistical strategy for project development and regulatory submission.

Direct or provide safety statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions. 

Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and development of safety data integration specifications in accordance with analysis plan.

Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies. 

Oversight of the development, delivery and interpretation of safety outputs, including graphics. Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines

Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Build interdepartmental relationships.

Provide oversight of cross-functional development of output specifications to address pre-planned safety analyses and ad hoc requests. Provide sufficient detail to allow programming implementation and ensure all statistical analyses specified in analysis plans are conducted appropriately. 

Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.

Train and mentor staff on safety statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative safety statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.

Develop safety strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.

Ensure that all applicable regulatory requirements for work processes are met, review regulatory submission documents, and represent DSS in discussions with regulatory agencies. 

Lead and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses.

Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.

Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation.

Stay current with industry trends and practices related to safety and potentially represent SSG/DSS on external initiatives to advance the safety discipline and build external scientific connections which foster professional development and promote the reputation of the Safety Statistics department.