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    Director, Statistical Programming

    Otsuka Pharmaceutical
    8-10 years
    Not Disclosed
    Rockville
    10 July 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Director, Statistical Programming

    Location: Princeton, New Jersey, or Rockville, Maryland, US (Remote arrangements considered)
    Travel: Up to 20% based on business needs
    Hybrid Work Policy: Otsuka maintains a hybrid work policy

    About Otsuka Pharmaceutical Company: Otsuka is a global healthcare leader committed to creating new products for better health worldwide. We focus on innovative pharmaceutical and nutraceutical products to address unmet medical needs and support everyday health.

    Role Overview: As the Director of Statistical Programming, you will play a pivotal leadership role within the Statistical Programming group. You will oversee statistical programming activities for clinical studies and projects within assigned therapeutic areas, ensuring high quality and timely deliverables. Your role will support the vision and strategy of both the Statistical Programming group and the Data and Analytics (D&A) organization.

    Key Responsibilities:

    • Leadership and Strategy: Develop and guide the strategy for statistical programming activities, ensuring adherence to standards, processes, and technology advancements.
    • Expert Advisory: Serve as a key advisor on programming strategy, offering insights into state-of-the-art practices, efficient coding techniques, and emerging technologies.
    • Resource Management: Maintain resource forecasts to optimize project allocation and manage resource utilization effectively.
    • Cross-Functional Collaboration: Partner with Clinical Management, Biostatistics, Data Management, and other teams to align on analysis and reporting deliverables.
    • IT and Infrastructure: Work with IT to build and maintain a secure statistical computing environment in compliance with 21 CFR Part 11.
    • Continuous Improvement: Collaborate with Statistical Programming leaders and the D&A Leadership Team to enhance processes, standards, and systems.
    • Stakeholder Engagement: Manage stakeholder relationships within D&A and across the organization.
    • People Management: Coach, mentor, and develop direct reports, ensuring training compliance and participating in the hiring process.
    • Vendor Management: Provide input for vendor selection and oversee vendor performance.

    Minimum Qualifications:

    • Master’s degree or equivalent with 15+ years of relevant experience.
    • 8-10+ years in Data Standards and Statistical Programming.
    • Extensive experience in the life sciences sector with a strong understanding of drug development processes.
    • Deep knowledge of regulatory requirements related to statistical programming, validation, and data governance.
    • Proficiency in SAS programming, relational database structures, and data workflow.
    • Strong understanding of CDASH, SDTM, ADaM, and CDISC controlled Terminology.
    • Excellent project management skills and ability to handle multiple projects simultaneously.
    • Strong leadership, communication, and interpersonal skills.

    Preferred Qualifications:

    • 8-10+ years of management experience.
    • Experience in CNS therapeutic areas.
    • Advanced degree in Epidemiology or Master of Public Health (MPH).

    Our Benefits:

    • Comprehensive medical, dental, vision, and prescription drug coverage.
    • Company-provided Life, AD&D, Short-term, and Long-term Disability insurance.
    • Tuition reimbursement and 401(k) match.
    • Generous PTO allotment, paid holidays, and other benefits.

    Competencies:

    • Accountability for Results: Focus on strategic objectives and high performance standards.
    • Strategic Thinking & Problem Solving: Make decisions with long-term impact in mind.
    • Patient & Customer Centricity: Prioritize the needs of customers and stakeholders.
    • Impactful Communication: Communicate clearly and influence effectively at all levels.
    • Respectful Collaboration: Value diverse perspectives and work towards common goals.
    • Empowered Development: Actively engage in professional development.

    Application Information: For more details about Otsuka and our benefits, visit Otsuka Careers.

    Otsuka is an equal opportunity employer. We encourage all qualified candidates to apply and will consider applicants regardless of race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

    If you require a reasonable accommodation to apply for this position due to a disability, please contact Accommodation Request.

    Disclaimer: This job description is intended to provide a general overview of the role. Responsibilities may be amended as necessary to meet business needs. Otsuka reserves the right to change job duties or responsibilities as required.

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