Principal Biostatistician

Role Overview: Statistics & Data Corporation (SDC) is seeking a Principal Biostatistician to apply a high level of technical expertise in guiding and developing junior biostatistics staff members. As a lead statistician on clinical studies, you will provide senior-level peer review and maintain the statistical integrity of clinical trials analyzed by SDC. Your responsibilities will include actively participating in various statistical tasks such as writing protocols, preparing data deliverables, interpreting analysis results, and supporting business development and project management activities. Key Responsibilities: - Serve as an internal consultant for biostatistics analysis tools and methods - Act as a subject matter expert during client and vendor meetings for biostatistics analysis support - Support business development by presenting capabilities to prospective and current clients - Manage assigned clinical study budgets for biostatistics analysis support - Coach and mentor junior biostatistics department personnel - Lead statistical analysis on clinical research projects and assist with SAS programming - Provide statistical expertise for the design of clinical trial protocols - Write statistical methods sections of study protocols and analysis plans - Review CRFs for consistency with protocols and statistical analysis plans - Program summary tables, data listings, and graphical representations of clinical trials data - Perform all defined analyses in the statistical analysis plan, including post-hoc and exploratory analyses - Prepare and review key sections of clinical study reports and regulatory documents - Conduct statistical QC of department outputs, including analyses and reports - Provide statistical support to external clients, such as FDA and Investigators - Contribute to SOP development, maintenance, and training - Represent the biostatistics department in regulatory and sponsor meetings - Manage biostatistics timelines, budgets, and client expectations - Adhere to quality system and data integrity & business ethics requirements - Perform other related duties as necessary Qualifications Required: - Effective leadership, budget forecast, and implementation skills - Excellent analytical skills for processing scientific and medical data - Ability to work independently and in teams - Project management abilities, including organizational and time management skills - Proficiency in statistical programming, particularly SAS - Strong communication skills to convey technical concepts clearly to non-statistical colleagues and clients - Familiarity with clinical trial design, analysis activities, and regulatory guidelines - Interpersonal communication and presentation skills for effective collaboration - Focus on quality and ability to collaborate across cross-functional teams About the Company: Statistics & Data Corporation (SDC) is committed to developing employees by offering growth opportunities, career advancement, flexible work schedules, engaging work culture, and employee benefits. The company values its culture of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment and provides a sense of belonging through fun and engaging activities. SDC has a proven track record of successfully executing client clinical programs since 2005, with a global presence and diverse perspectives supporting growth in the industry. Note: No additional details about the company were provided in the job description.,