At a team/site/staff level, provide advanced technical expertise to develop process methodology for department to meet internal and external clients' needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
• Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically.
• Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
• Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies.
• Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
• Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
• Use and promote the use of established standards, SOP and best practices.
• Provide training and mentoring to SP team members and Statistical Programming department staff.
• Bachelor's Degree Maths, Computer science, Statistics or related field and 4 years relevant experience Req Or
• Master's Degree Maths, Computer science, Statistics or related field and 3 years relevant experience Pref
• Typically requires 7+ years of prior relevant experience
• Equivalent combination of education, training and experience in lieu of degree
• Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
• Advanced knowledge of statistics, programming and/or clinical drug development process;
• Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language, where applicable
• Excellent organizational, interpersonal, leadership and communication skills
• Excellent accuracy and attention to detail
• Aptitude for mathematical calculations and problem solving
• Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM)
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
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