US-MA, Scientific Fellow R0002844-MZ
OBJECTIVE: (Briefly summarize the overall purpose of the position. Objectives should be written in 3 4 statements).
* Provide statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level and/or therapeutic area (TA) level, promoting innovative design and analysis methodology. * Provide strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions and interactions. * Independently represent Statistics function in interactions with regulatory authorities and statistical working groups. * Monitor and implement advances in statistical and clinical trial methodology for assigned compounds, and promote use of innovative methodologies across TAs.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Approximately 5 10 task statements should be identified).
* Independently represent the statistics function on global therapeutic areas in support of clinical studies and compound and/or TA-level programs. * Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across therapeutic areas, including timelines. * Promote innovative clinical trial designs and efficient analysis methodologies * Provide statistical leadership in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAs as appropriate. * Oversee standards of definition and implementation of therapeutic area level database (including derived database), analysis and reporting standards. Collaborate with Data Management, Programming, Safety Statistics, Clinical and PV to provide suggestions for achieving high quality databases and specifications. * Oversee compound and/or TA-level analysis and reporting activities. * Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson. * Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, global integratability and sharing of best practices. * Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management * Monitor and contribute to industry advances in statistical methods to optimize study
designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAs as appropriate.
EDUCATION, EXPERIENCE AND SKILLS: (List the education and experience required to perform the primary responsibilities of the job. Equivalent combinations of education and experience should be noted).
* PhD in statistics or biostatistics with a minimum of 8 years of relevant experience or MS in statistics or biostatistics with a minimum of 12 years of relevant experience. * Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures Extensive statistical and operational knowledge in at least one therapeutic area * Demonstrated successful track record in working with various development teams * Active in statistical/pharmaceutical professional organizations at regional or national level. * Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents. * Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials. * Experience consulting and/or independently representing Statistics function in interactions with regulatory agencies * Excellent oral and written communications skills. * Expertise in statistical programming, modeling and simulations
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