Therapeutic Area Lead, Data Analysis Reporting (Director)
Pfizer - La Jolla, CA

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Role DescriptionAs CII’s Data Analysis Reporting key strategic and operational execution partner and primary point of contact to Global Business Segments Therapeutic Areas, including Development Operations, this position provides leadership and expertise in Data Analysis Reporting operations. Ensures internal and external data analysis reporting operations to advance research, development, and commercialization of the Pfizer portfolio Provides managerial oversight of colleagues and deliverables from CII Data Analysis Reporting Leads a team of Data Analysis Reporting colleagues that are points of contacts (PoCs) for designated assets within Therapeutic Areas. Performs duties of a CII Data Analysis Reporting Lead/Group Lead - Points of Contact (PoC) as needed Responsible for consistent harmonized processes and high quality clinical trial data deliverables for clinical projects in partnership with statistics/Business Unit Accountable for delivery of functional area goals Provides managerial leadership of strategies for the group/TA and specific implementation of technology-enabled processes Works closely with the Data Analysis Reporting Head and other CII groups in formulating strategies and standards to be implemented for all programs and to take responsibility for the implementation at external resource suppliers Create, maintain and assume accountability for a culture of high customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines ResponsibilitiesManages team of CII Data Analysis Reporting Leads and Data Analysis Reporting Group Leads/PoCs to deliver data analysis reporting operational services (particularly in the programming space) to business segments/therapeutic areas, in a high quality and timely manner, and within CII metrics goals Is accountable for the implementation of data analysis reporting/clinical programming activities for submissions, scientific and commercialization support, and studies, related to the drug programs Serves as lead subject matter expert for data analysis reporting/programming. Understands and anticipates business priorities, products, and information needs Intimate knowledge of therapeutic/scientific, or other specialized domains (e.g.

outcomes, safety surveillance, clinical pharmacology, drug research, etc), related to therapeutic area Ensures all CII activities under remit conform to applicable standards, such as Pfizer clinical data standards, and are in compliance with relevant regulatory requirements Works with DevOps, therapeutic area peers to resolve cross-functional barriers to achieving CII milestones. Actively oversees project milestones and manages inconsistencies through networking with relevant project managers Ensures appropriate resources are identified and engaged to support the therapeutic area portfolio Perform duties of CII Data Analysis Reporting Lead and/or CII Data Analysis Reporting Group Lead/Point of Contact as needed Develops charters, resource utilization and project plans to achieve CII and functional area specific goals Provide administrative and CII technical and process oversight of group In strong collaboration with other CII colleagues or Development Operations functions (peers and group heads): –Contributes to cross DevOps initiatives –Implements strategies to ensure consistent processes –participates in specific process improvement initiatives; monitors and reports on implementation progress as appropriate Implements organizational design and develops succession planning for own group and for functional area in collaboration with other CII group leads Actively develops people: –Recruits high caliber staff –Provides focused career development –Provides performance management –Manages retention Champions operational excellence to provide continuous improvement of processes and sharing of best practices across all Development Operations, Business Segments, and Alliance Partners. Ensures appropriate process and documentation with respect quality for inspection readiness.QualificationsBachelor or Master Degree in Statistics, Biological Sciences, IT or related field. An advanced degree ( M.S., Pharm D, M.D., or Ph.D.) is desirable Background in Research or Business Unit clinical programming (i.e., SAS) and statistics strongly preferred Demonstrated expertise with data and processes (data management, programming, statistics, technologies, standards) associated with pharmaceutical research and development Thorough understanding of regulatory requirements and relevant data standards Knowledge of vendor processes and best practices in outsourcing.

Must be capable of building strong relationships with Alliance Partners and other vendors. Evidence of strong leadership, influencing, negotiation, and management skills Prior Experience Preferred At least 4 years leading a substantial group responsible for data analysis reporting/clinical programming and/or biometrics management function, or equivalent At least 10 years experience in a pharmaceutical, biotechnology, research, or regulatory setting Extensive clinical development and business experience in order to have a thorough understanding of the processes including clinical programming Experience leading the data analysis reporting and clinical programming components of regulatory submissions required History of achievement in a customer service role demonstrating ability to meet customer needs and address concerns and in building strong customer relationships, evidenced by positive feedback from customers Experience in leadership, project management, resource management (staff and financial) are required Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. Technical Competencies Demonstrated knowledge and success in managing multiple clinical programs, clinical programming and writing technologies and processes. Thorough understanding of Clinical Programming and writing systems and Pfizer Data Standards.

Demonstrated ability to manage complex projects and processes. Established history of timely and quality delivery. Demonstrated knowledge of clinical development and regulatory submission processes and requirements. Demonstrated success/results in prior scientific/administrative management roles.

Knowledge/proficiency/understanding of technologies to support clinical programming and writing; understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption. Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations. Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget. Extensive knowledge of vendor processes

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