[R&D] Staff, Clinical Data Scientist (PMS)

Key Skills

Apache Hadoop, C Programming, C++, Data science techniques, Java Programming, Machine learning techniques, MapReduce, Python Programming, PyTorch, R Programming, Scala Programming, SQL, TensorFlow

Job Description

Clinical Data Scientist (CDS) serves as point of contact for data management strategy and operations in Pfizer Japan and provide central accountability for ensuring timelines and deliverables to be met with consistency, efficiency and quality.

Primary Role & Responsibility

• Serves as point of contact for providing responses to internal audits as well as regulatory inspections with regard to data management activities
• Mitigates/arbitrates technical and process issues on PMS data management with CROs and solution vendors
• Leads new Pfizer PMS data collection environment by successful implementation and maintenance of the systems and related processes
• Works with BPOs to review performance metrics against targets to ensure program deliverables are being met and productivity is aligned with Pfizer expectations
• Ensures appropriate data standards, system and processes are used and implemented consistently across the programs
• Applies and drives lessons learned to continuous improvement of data management practices across the organization with internal/external customers
• Leads implementation of PMS data collection standards into each surveillance

Desired Behavioral and Technical Skills

• Behavioral Skills
• Flexibility and implementing change: Responds positively and constructively to changing situations and manages change by identifying opportunities and coaching self and others through the change
• Customer Focus : Identifies and builds effective relationships with customers and other stakeholders
• Ownership: Be accountable for data quality to internal and external customers to ensure confidence in data.
• Technical Skills
• Clinical Data Management expertise : Extremely Extensive knowledge of clinical development process and principle including in-depth knowledge and understanding of the principles of GCP/GPSP as well as CRF design, database design and set-up, query management and validation specs, data browsing tools and outsourcing
• Communication: shares best practices and any visible and/or potential issues with appropriate members in timely manner.
• Experience
• Industry experience in order to have a thorough understanding of the processes associated with clinical drug development and operations (especially in supporting the data management and reporting components of regulatory submissions and product defense) as well as in developing/implementing new standards, systems and processes.
• Education
• Minimum of a Bachelor degree in biological sciences, statistics, IT, medicine or related scientific discipline.
• Language
• Level where they can discuss, debate and negotiate with global colleagues and external customers

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