Job Abstract

Purpose:

The Senior Manager, Statistics provides statistical leadership to support the research and development organization for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.

description: 

Responsibilities:

• Protocols: Explore and select study designs aligned with Project Team strategy and goals. Provide sample-size, develop randomization specifications, and independently write statistical analysis plans to address study objectives. Ensure alignment of protocol with project and functional standards. Conduct quality review of protocol. Implement randomization schedules as planned with Interactive Response Technology vendor, Global Drug Supply Management, and other partners.
• Database Activities: Ensure data collection instruments are adequate and data collection is free of bias. Ensure database design satisfies statistical analysis requirements. Contribute to data monitoring plans. Develop and implement project-specific data standards. Identify and report data issues or violation of study assumptions. Guide programmers and data managers in preparing for database lock. Ensure accuracy of data released for statistical analysis.
• Statistical Analyses: Independently evaluate alternative complex or novel statistical approaches, make recommendations, approve, and implement. Influence non-statisticians to accept approach. Develop analysis plans ensuring statistical methods are appropriate with detail for programming. Ensure internal consistency of analysis plans. Perform statistical analyses per the SAP. Determine the need for development of novel statistical methodology.
• Reports and Publications: With project team, develop strategy for data presentation and inference. Independently write statistical methods and other sections of protocols, publications, etc., ensuring document templates followed. Identify and implement corrections to flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses conducted as planned with accuracy and internal consistency of writing including tables, listings and figures.
• Consultation: Work collaboratively with multi-function teams per agreed timelines. Timely inform management on important scientific/statistical issues that may arise. Provide responses to questions from clients and independently pursue analyses suggested by data. Effectively and persuasively present statistical concepts, evidence, assessment of risks and impacts. Demonstrate an understanding of drug development principles.
• External Engagement: Act as the liaison for statistical and operational issues on PCYC collaborative studies with Academic and Contract Research Organizations. Communicate with statisticians outside PCYC concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department.
• Project Team Involvement: Represent the department on project team(s) to provide functional area input to compound/drug development. Serve as a liaison between the project team and the department to ensure timely communication of project team updates, proper statistical strategies, and alignment of decisions/priorities between the project team and functional area.
• Training and Mentoring: Maintain technical skills and increase knowledge of new statistical methods and areas of application through scientific literature and professional meeting attendance. Present own research or review of literature at meetings. Participate in departmental activities including recruiting, training/mentoring, research efforts, and cross-functional collaborations, as needed.
• Regulatory Activities: Participate with department management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies.
• 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. Responsibly maintain department standards, GxP compliance, and best operating practices. Complete all assigned training on time.