The Head of Biometrics will be responsible for developing the vision for Biostatistics and Statistical Programming in alignment with Janssen AI's objectives. Define role and contribution for statisticians and statistical programmers within the organization. Foster collaboration between the Biometrics personnel and their colleagues within R&D. Define optimum structure and provide for flexibility for shifting priorities. Accountable directly or through subordinates for the statistical strategy and designs in all projects for full compound development and product life cycle. Provides input to clinical development plans, protocols, clinical study reports, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy. Oversees and manages the day-to-day functions of Biometrics; including setting objectives for the overall department and for individual members of the department. Contributes strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed. Responsibilities include resource planning; interviewing, hiring, and training employees; establishing priorities; providing oversight with regard to quality standards; setting objectives; appraising performance; fostering career development; rewarding and disciplining employees; addressing complaints and resolving conflicts. Writes and/or reviews SOPs for Biometrics and is accountable for the overall compliance and quality of the Biometrics deliverables. Accountable, directly or through subordinates, for all Biometrics activities in clinical trials, including but not limited to: Reviews regulatory documents for accuracy and statistical interpretations, and provides statistical consultations and strategic inputs in terms of drug development for company's senior management and other staff within the company, and communicates with regulatory bodies and vendors (such as CROs) on statistical issues. Lead the Biometrics Leadership Team responsible for ensuring that statistical policy, procedure, SOPs, roles and responsibilities align with other functions in R&D Responsible for ensuring that the statistical programming environment meets corporate needs and is compliant with all regulations

A Ph.D. degree in Biostatistics or closely related field is required. A minimum of 15 years of pharmaceutical experience with at least 5 years of management level experience. International experience is strongly desired. Excellent verbal and written communication skills. Must have a working knowledge of filing regulatory documents and complex statistical methods that apply to all phases of clinical trials. Strong attention to detail and accuracy is a must. Ability to effectively present information to senior management, regulatory authorities, public groups, and other departments. Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness. Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships. Demonstrated ability to proactively maximize relationships to enable successful collaboration. Demonstrated ability to facilitate a beneficial resolution of conflict. Ability to articulate a clear vision and help others understand their relationship between their roles, the roles of others and the overall goals of the organization; ability to articulate the reason behind organizational changes and demonstrate flexibility, energy and resilience throughout change efforts. Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes; ability to work in diverse teams to optimize decision-making. Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals. 10-15% International and Domestic travel is required.