Head, Biometrics

Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. The Opportunity: Head, Biometrics: Provide leadership and vision for the Biometrics team; responsible for setting, designing, and developing the vision and goals for Biostatistics, Statistical Programming, Data Management, and Medical Writing, translating the strategies into tactical plans and actions. Managing Biostatistics, Statistical Programming, Data Management, and Medical Writing resource allocation to support all clinical trial projects. Supervising the Biometrics team including professional development, target setting, performance management, mentoring, and recruitment, as needed. Assists in the development of SOPs and work procedures for biostatistics, statistical programming, and data management. Provide statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements. Reviews or authors statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents, and scientific publications; generates or reviews study randomization and sample size/power estimations. Reviews case report forms to ensure that protocol objectives are met, and project standards are maintained. Oversees the development of statistical programs as needed to perform pre-specified or ad-hoc analyses and prepare data displays, simulations etc. Provides statistical input for global regulatory submissions such as FDA and EMA. Serves as the liaison with statistical and operational aspects pertaining to Data Monitoring Committees. Performs and reports study results of appropriate statistical analyses, in collaboration with clinical development, to provide appropriate interpretation of data and sound study conclusions. Collaborates with other functions to ensure data collection and reporting is done in conformance with ongoing practice and regulatory expectations. Adheres to FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development. Becomes familiar with the disease states and therapeutic space to enhance the level of collaboration and be able to evaluate implications of study designs. Oversees statistical and programming deliverables by CROs (e.g., SAPs, CDISC data, Define.xml). Additional duties assigned as needed.