MGR CDM PROGRAMMING

40.000.000 - 80.000.000


Work Schedule Other Environmental Conditions Office Job Description Manages a small team within the department responsible for the bioinformatics programming aspects of clinical trials from design through analysis and reporting. Acts as the lead programmer, project lead, or oversight lead, overseeing both statistical and programming aspects of clinical trials across multiple projects. Represents the department to clients on study matters, bid defenses, or submission of clinical data to regulatory authorities. Contributes to proposals and bids, organizes teams, implements study strategies to ensure process and programming efficiencies, and maintains programs for statistical report generation and validation. Manages staff, including interviewing, hiring, professional development, goal setting, performance management, coaching, counseling, and separations. Approves salary actions, hires, corrective actions, and terminations. Reviews and approves time records, expense reports, leave requests, and overtime. Promotes adherence to Equal Employment Opportunity policies and ensures compliance with scientific, ethical, and regulatory standards. Serves as a lead programmer or project lead on studies of varying complexity. Works directly with teams and clients to conduct meetings, develop project timelines, assess resources, and manage budgets and contractual obligations. May serve as a senior project oversight or contributor/reviewer for regulatory submissions. Provides infrastructure support, including representing the company at industry conferences, developing training materials, contributing to policies, and process improvements. Enhances personal and team knowledge in programming, clinical trials, and industry developments. Increases the company's visibility through publications and conference presentations. Interprets and applies policies and procedures, with full knowledge of the area of responsibility. Qualifications: Education and Experience: MS/MA in computer science, statistics, biostatistics, mathematics, or related field with at least 3 years of relevant experience, or Bachelor's degree in a related field with at least 5 years of relevant experience. Preferred: At least 6 years of clinical trial experience as a statistical programmer and 1 year of leadership experience. Knowledge, Skills, and Abilities: Strong SAS programming skills and understanding of database structures. Excellent organizational skills and ability to manage multiple projects and adapt to changing priorities. Effective communication skills in English, both written and verbal. Ability to work in multidisciplinary teams. Basic knowledge of statistical principles in clinical trial design and analysis. Ability to contribute to policy development and decision-making. Strong problem-solving, supervision, and mentoring skills. Attention to detail and ability to facilitate communication with clients and teams. Understanding of project budgeting, risk management, and clinical trial guidelines (ICH, GCP). Focus on delivery and quality assurance. #J-18808-Ljbffr

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