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Manager, Statistical Programming / Principal Statistical Programmer Nr ref.: /JOBS.pl Principal Statistical Programmer / Manager, Statistical Programming (home or office based) in UK or Mainland Europe. This is a fantastic opportunity for an experienced statistical programmer to develop their career further into a management role. The role has around 70% lead programming responsibilities, and 30% line management duties. We will consider an accomplished statistical prgrammer looking to make this next step. Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,000 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include Clinical Development, Oncology, Device & Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision. Chiltern International (CRO) is currently searching for a talented and dedicated individual to assist with leading a team of Statictial Programmers. The role will be Principal or Manager level, depending on experience. This is a dual role with responsibilities for both hands on lead programming activities as well as line management and supervisory duties. The position is to be located in Europe (can be office or homebased , depending on location). STATISTICAL PROGRAMMER RESPONSIBILITIES Coordinate programming activities for several clinical research projects Serve as the statistical programming lead on internal project teams and coordinate/perform programming, verification, and documentation of statistical programs for use in creating analysis datasets (SDTM, ADAM, Define.xml), tables, listings, and figures Identify project priorities and project timeline goals and communicate priority-related issues, status and timelines to programming teams and department management Facilitate advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project applications that are supported by the department Contribute to ongoing improvement of programming processes and methodology through active monitoring of new technologies, participation in user groups/conferences (e.g. CDISC, SAS global forum, PhUSE) Promote, communicate and enforce programming code standards Represent the department and the company in client and other external meetings/presentations and maintain a positive working relationship with sponsors, collaborating associates, and vendor personnel Lead and organize project programming tasks, typically for multiple protocol, integrated analysis or otherwise complex projects Lead and support relevant other projects as subject matter expert (e.g. infrastructure projects, creation of multi-use programs, medical review tools) MANAGEMENT RESPONSIBILITIES Manage and mentor statistical programming staff as appropriate; provide direct supervision and review work of limited assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures Serve as a model of effective time management, communication, and utilization of resources. Provide leadership and motivation to departmental personnel Identify training and development needs of people in the department, orientation, and job training as appropriate Assist in the development, implementation, and delivery of departmental training programs Assist in ensuring the optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices Assist in the interview and selection of qualified personnel To liaise with other members of the project team, clients, external vendors and contractors effectively To maintain awareness of current development in the therapeutic areas relevant to his/her project(s) At all times to promote the image of Chiltern, acting as an ambassador for the Company Ensure that all internal systems are routinely updated as appropriate (e.g. timesheets, expense reports, financial reports, etc.) Define achievable goals and tasks as related to a departmental objective or initiative. Identify areas for improvement (e.g. SOPs, processes, etc.) REQUIREMENTS Masters degree or higher in Statistics, Mathematics, Computer Science, or related field. Extensive experience leading statistical programming activities in clinical research Management or supervisory experience Expertise in SAS programming (Base SAS®, SAS/STAT®, SAS/GRAPH®, SAS® Macros and SAS® SQL) Knowledge of SAS® stored processes Knowledge of scripting languages other than SAS® (e.g. VB, JAVASCRIPT) Knowledge of at least one web-development language (e.g. HTML, XML) Expert numerical abilities and analytical skills with thorough understanding of clinical trials and their data flow. Expertise in data integration Experience in working according to CDISC standards including the creation of submission-ready datasets Knowledge of relevant laws, standards and guidance for clinical development (FDA, EMA, ICH-GCP, local regulations, etc.) Demonstrated knowledge of computer system validation concepts, methodology and its application in clinical trials Previous use of business intelligence and data warehousing technologies Solid understanding of database theories Proven planning and project management skills Excellent verbal and written communication skills Experience of working collaboratively and informatively with other disciplines with the Sponsor and within Chiltern (e.g. Clinical, Biostatistics, Data Management, IT) Fluent in English (written & spoken) At Chiltern, you'll join a team of like-minded individuals headed by some of the most dynamic and influential leaders in drug and medical device development today. You'll work on cutting-edge global research projects in a fast-paced but collegial atmosphere where you'll have the opportunity to make meaningful - and acknowledged - contributions. You'll have opportunities to grow personally and professionally and abundant room for advancement along with generous incentive programs. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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