JOB SUMMARY

• Set and drive the biometrics vision and strategy for R&D within China across early and late development, ensuring alignment with overall global R&D objectives.
• Forward thinking in innovative trial designs to support China development and approval, new AI applications in biostatistics, statistics expert leader liaising with Chinese regulatory in driving local guidance and regulations.
• Partner effectively with global and China Clinical Development, Regulatory Affairs, Safety, Clinical Pharmacology and Real World Evidence, and other functions.
• Site leader responsible for ensuring the provision of statistical expertise in support of Therapy Areas, Programs and Projects in partnerships with colleagues both inside China and at global sites outside of China
• Accountable for the timely delivery of high quality statistical deliverables including Clinical Trial Protocols, Statistical Analysis Plans, input to Clinical Study Reports and other deliverables as required
• Expected to effectively manage utilization of local statisticians to ensure planned activities and deliverables are adequately resourced and agreed milestones met, and that colleagues are fully engaged in supporting the business
• Functional leadership ensuring use of agreed standards, compliance with specified training curriculum, adherence to relevant SOPS and processes and utilization of specified systems and software
• Technical and functional development among local statisticians ensuring hires suitably qualified, that their statistical skills are developed in line with business need, and that they have a strong awareness and understanding of NMPA, EU and US regulatory, ICH guidance documents
• Responsible for ensuring local statisticians are equipped with necessary competencies to carry out their duties including team-working skills, the ability to communicate technical and non-technical matters clearly, good time management and organizational skills, etc.
• Leadership in outreach activities building effective links with external industry, academic, professional and other local and national institutions and organizations
• Establish and maintain links with statistics heads at other sites to ensure alignment in strategy and implementation
• As needed, provide guidance to local statisticians on technical and statistical matters

JOB RESPONSIBILITIES

In addition to carrying out duties in support of primary purpose as above:

• Provide administrative and technical oversight of the site statistical function
• Serve as a senior thought partner to China R&D leadership on trial design, data interpretation, and risk mitigation.
• Ensure development and implementation of site-specific change management based on global strategies and standards and in collaboration with other site functions.
• Develop people, including recruitment, retention, and career development.
• Foster a culture of scientific excellence, collaboration, innovation, and continuous improvement.
• Be accountable for statistical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects at the site.
• Implement strategies to ensure that the statisticians are collaborative, strategic partners with scientific and clinical colleagues.
• Implement strategies to ensure appropriate consistent processes in strong collaboration with associated global development areas.
• Implement strategies to ensure speed and quality, fully integrated global data analyses on individual studies and for submissions.
• Implement aligned strategies and consistent processes to optimize the use of corporate standards
• As opportunities permit, provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice; and encourage/sponsor research

QUALIFICATIONS / SKILLS

• Postgraduate statistical qualification (PhD in Statistics, Medical Statistics or similar) with extensive clinical development and business experience.
• A thorough understanding of the processes associated with clinical, regulatory and marketing operations.
• Leadership, project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Experience supporting regulatory submissions and post-marketing activities
• At least 7 years of experience in managing multiple, highly complex projects.
• At least 3 years staff management experience.
• Demonstrated project management and budget management expertise required.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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