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- 2009-5-28
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然后另外一个中国人很多的地方/state,Sr. 职位
-baidu 1point3acres
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Sr Biostatistician .--
Description: Position Summary
• Provides consultation services to Clinical Project Leader on study design issues and develops statistical methods section of the protocol.
• Develops tables of contents and templates for reporting study data and results to meet regulatory standards; performs statistical analysis of study data with particular emphasis on efficacy/outcome data.
• Provides specifications to programmers for generation of SAS analysis datasets for both efficacy and safety analyses; performs validation of key statistical results; and provides expertise to protocol development and experimental design, analysis, and reporting.. From 1point 3acres bbs
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Job Responsibilities
• Prepares detailed Statistical Analysis Plan (SAP) to meet regulatory standards.
• Reviews study protocols, CRFs, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data..--
• Produces table templates for reporting of study results and data.
• Coordinates data and table review activities among the project team members..
• Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and works closely with Medical Writing in study report preparation.
• Responds to questions from the FDA and other regulatory authorities on statistical issues.
• Develops templates for ISS and ISE statistical tables for NDA submission in conjunction with clinical, and provides specs and supervision for production of ISS and ISE tables.
• Reviews ISS and ISE reports towards NDA submission.
• Performs statistical analysis for publication.
• Provides specifications to programming for generating analysis data sets..
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Knowledge, Skills, and Competencies
Knowledge
• Requires understanding of the company’s products, the competition, and the pharmaceutical industry in general
• Maintains current awareness of new drug developments in the business. . 1point 3 acres
Skills
• In-depth knowledge of statistical principles, applications and SAS programming software
• Knowledge of current industry and regulatory submission practices, protocol designs, and terminology.
. .иCompetencies
• Adaptable — Adjusts readily and effectively to frequent changes in the work, processes, and requirements of the position; tries to understand change and quickly adjust focus and behavior; able to adjust to new leadership, new ways of doing things, and new priorities.
• Ability to collaborate — Works effectively and cooperatively with others (including clinical, regulatory, medical affairs, data management, medical writers, investigational material department, and safety); proactively shares information and ideas; obtains input and direction, listens, and provides necessary communication; ensures all necessary individuals and groups are engaged and involved; fulfills commitments made to the team; demonstrates respect for others’ ideas.
• Strong oral and written communication skills — Clearly conveys information and ideas to individuals and groups (internal and external); makes it a point to communicate regularly to peers, team members, subordinates, and/or managers; effectively organizes information; maintains and adjusts to audience; ensures understanding; comprehends communication from others; provides clear and effective training to internal and external groups.. 1point 3 acres
• Continuous learning — Makes specific efforts to improve and expand technical knowledge and skills; identifies new areas for learning; regularly creates and takes advantage of learning opportunities; uses newly gained knowledge and skills on the job; takes initiative to discover information about industry regulations and standards.
• Strong decision making and judgment — Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions and uses effective approaches for choosing a course of action or developing appropriate solutions; exercises appropriate judgment and involves others to obtain information; considers potential risks and makes the most appropriate decisions; communicates with all appropriate parties and ensures understanding of the resulting decisions.
• Driving for results with quality — Consistently produces quality results; completes tasks and projects requiring a great attention to detail; appropriately balances the need to meet deadlines with the requirement for quality products that produce strategic value; establishes stretch goals for self and others; works tenaciously toward achieving desired results.
• Global vision — Thinks globally in terms of commercialization; knows global regulations and protocols; demonstrates cultural sensitivity and works well with people globally; understands what we do as a company even though may not know the details and how they fit in.
• Managing through influence — Motivates and manages the performance of colleagues over whom he/she does not have direct authority; works with and appropriately influences many kinds of team and project members; pushes tasks and decisions down; invites input from others; provides appropriate feedback; steps up to conflicts and handles in an appropriate manner; can find common ground and get cooperation with minimum noise.
• Ability to multi-task and effectively prioritize work and projects — Manages and completes multiple tasks and projects at a time; allocates own time to complete work and coordinates own and/or others’ schedules; identifies more critical and less critical activities and tasks and adjusts priorities when appropriate; uses time appropriately to ensure work is completed effectively and efficiently.
• Problem solving — Consistently solves difficult problems with effective solutions; anticipates and identifies core problems, can see underlying or hidden problems and patterns and look beyond the obvious to solve problems effectively; asks good questions and probes for answers; applies insightful analysis; confronts tough or difficult issues.
• Ability to be an effective team leader and/or team member — Comfortable sharing information and working in teams; uses appropriate methods and a flexible style to help build a cohesive team and facilitate the completion of team goals; involves and informs others; models commitment to team expectations and responsibilities; finds ways to help the team accomplish goals.
Physical Demands and Work Environment
See attached.
Education and Related Experience
PhD in Statistics/Biostatistics with 1 year of experience in Phase II/III clinical trials. |
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