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Clinical Data Manager III

Company: AbbVie
Location: Sunnyvale
Posted on: November 11, 2019

Job Description:

General Position Summary/Purpose:Provides scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug discovery or development strategies for assigned project; for the design, analysis, and reporting of scientific research trials; and for interacting with regulatory agencies regarding the results of these activities.Key Accountabilities/Core Job Responsibilities:

  • Protocols: Direct development of statistical designs and analysis procedures for scientific protocols, ensuring they are scientifically sound, aligned with project strategy, meet regulatory objectives and make optimal use of the data to be collected. Ensure statistical analysis plan is methodologically sound and consistent with objectives of the protocol. Assist in developing project and functional standards of data collection and analysis, and implement these standards.
  • Database Activities: Collaborate with Clinical Data Management, Statistical Programming and other stakeholders to ensure data collection instruments and database implementation meets short and long-term project needs. Contribute to data monitoring plans. Develop and implement project-specific data standards. Ensure accuracy and consistency of data released for statistical analysis.
  • Statistical Analyses: Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Determine need for development of novel statistical methodology.
  • Reports and Publications: Ensure that study results and conclusions are scientifically sound, clearly presented, and supported by statistical analyses. Prepare oral and written reports to communicate results. Represent Data and Statistical Sciences on project issues at management review and project team meetings. Provide in-depth statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and publications with high quality.
  • Consultation: Interact with stakeholders so that statistical methods are adequately and consistently applied in all deliverables. Provide statistical insight in addressing questions and propose novel solutions to technical issues. Independently pursue analyses suggested by data, including the pursuit of statistical knowledge needed.
  • External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures, CROs or licensing activities. Build external scientific contacts which foster professional development and promote the reputation of the department. Work with Director to build relationships between CDM and outside investigators and medical/scientific experts.
  • Project Team Involvement: Partner with Clinical and Regulatory to create development strategies for assigned project. Represent department on project team(s) to provide statistical input to compound/drug development and align with functional management. Lead communication between assigned project team(s) and department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional management.
  • Training and Supervising: Train and mentor staff on statistical methodology and operations. Participate in department seminars, short courses and presentation of scientific articles. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff. People managers will manage 2 or more direct reports.
  • Regulatory Activities: Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to meet SOPs and regulatory requirements.
  • Compliance: Compliant with applicable corporate and divisional policies, procedures and cultural values. Maintain up-to-date knowledge of Standard Operating Procedures and working practices relevant to managers and the Statistics function. Ensure compliance with department standards, GxP and best operating practices for staff and self. Complete all assigned training on time
    • Excellent oral and written English communication skills.
    • Broad knowledge of, and compentence in, statistical methodology including experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming and experience in applied statistics/statistical consulting.
    • At least 10 years (MS) or 6 years (PhD) of experience in pharmaceutical development. Understanding of global regulatory requirements. Experience interacting with regulatory agencies highly desirable.
    • Management experience highly desirable for people managers. Education and Experience:
      • MS (with a minimum of 10 years of experience) or PhD (with a minimum of 6 years of experience) in Statistics, Biostatistics, or a highly related field.

Keywords: AbbVie, Sunnyvale , Clinical Data Manager III, Executive , Sunnyvale, California

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