Director, Biostatistics, Planning and Integration Lead

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

This position of Biometrics Planning and Integration Lead manages the biometrics deliverables for key drug development projects in a matrix environment. This position leverages leadership, vendor management, strategic thinking and problem-solving skills to drive consistency and operational excellence in the planning and delivery of key Biometrics data operations, dataset development, analyses and reporting through their partnership with the Biostatistical, Programming and Data Management Leads/Teams. This individual has proficiency in clinical development, biometrics, and project management and provides strategic insight into both, standard and innovative processes and related technologies that support analysis and reporting activities. This role has significant interfaces with other functions within R&D, with development partners and vendors and is accountable for tracking Biometrics timelines for critical studies, which may include data cleaning, data set generation, analyses and reporting of Phase I - Phase IV clinical trials.

Job Description

• Translate company and departmental strategies into operational goals. Identifies necessary resources to accomplish goals and develops effective and strategic approach to delivery against the goals, in accordance with R&D priorities/timelines/strategies.
• Partners with Biometrics Leads/teams to evaluate operational readiness to meeting R&D pipeline objectives. Provides risk assessment of deliverables and follows the escalation pathway when warranted.
• Provides leadership for ensuring Biometric deliverables are delivered on time with quality for both internally or externally supported deliverables.
• Able to represent Biometrics function as an SME for effectively partnering with various cross functional stakeholders to deliver the R&D BoW. This role interacts with many stakeholders across the Development organization such as PS&AM, Regulatory, Clinical, and Operations, to align on timelines for biometrics deliverables and to provide key input into planning and risk management for upcoming milestones.
• Ensures timely planning of resources (both internal and external) to support both pipeline objectives and continuous improvement work and helps drive prioritization/tradeoff discussions
• Accountable to coordinate and conduct routine Biometric Milestone reviews and management meetings with D&A LT and necessary team members (BoW management, resources and portfolio reviews including risks and mitigations).
• Ensures regular governance with vendors including quality agreements, scorecard review, and input obtained from key Biometrics stakeholders to obtain input on vendor effectiveness
• Establishes and evaluates metrics to understand Biometrics Team effectiveness and identify emerging trends (includes across vendors and partners).
• Leads or supports Biometrics-related initiatives focused on continuous improvement, simplification of processes or cycle time improvements
• Mentors and models to Biometrics staff the contributions of the role and strong communications and project management.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Graduate degree in and/or relevant experience in statistics, biostatistics, computer science or other related discipline
• At least 10 years of Pharmaceutical/R&D or other related experience in a regulated environment
• Extensive knowledge of analysis and reporting deliverables for clinical trials
• Extensive experience managing multiple, complex vendor relationships on clinical trial related activities
• Superior project management skills/experience with proven ability to manage timelines and resources across large teams/projects
• Significant experience with regulatory submissions and/or other regulated activities (Market Access, Annual Reporting, Clinical Trial Transparency)
• Demonstrated success working with Development, Regulatory, Documentation, Clinical, and Operations Leads to understand strategic objectives and priorities, and able to use this knowledge to focus teams on the right work
• Proven ability to mentor junior staff and propose/lead continuous improvement initiatives

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role i