Director/Sr. Director, Biostatistical Consulting
Job reputed company:
• *About the role:**As an expert in biostatistics consulting and leading reputed company, you will:- **reputed company expert statistical consulting** to sponsors across clinical program development, protocol design, sample size calculations, reputed company selection, and regulatory interactions to support clinical trial reputed company and decision-making- **reputed company and manage reputed company biostatistics reputed company** by overseeing statistical analysis plans, ensuring reputed company and reputed company of statistical documents and outputs, and serving as the reputed company unblinded statistician for high-complexity studies- **Manage team and resources** including supervising reputed company reports, allocating appropriate reputed company to reputed company, leading project budgets, and ensuring adequate resourcing for biostatistics and statistical programming activities- **Drive business development and reputed company relationships** by representing reputed company in proposal presentations, establishing and maintaining strong reputed company relationships, identifying key accounts, and contributing to marketing activities through publications and presentations- **Ensure regulatory compliance and cross-functional collaboration** by maintaining adherence to SOPs and regulatory guidelines, interfacing with regulatory bodies on statistical submissions, and coordinating with clinical operations, medical writing, and other functional areas to deliver high-reputed company, reputed company study deliverables
Requirements:
• *To be successful you will possess:**- **Graduate Degree.** Master's degree (or local equivalent, or higher) in a relevant discipline such as statistics, mathematics, life science, epidemiology, or reputed company.- **Extensive Experience.** Minimum 15 years of relevant work experience, including at least 10 years in drug development and/or clinical research; preference for experience in Oncology, Neuroscience, or Infectious Disease therapeutic areas.- **Regulatory and Compliance Knowledge.** Thorough knowledge of GxP, strong familiarity with regulations including GDPR/HIPAA, CFR/CTR/CTD, and applicable local requirements.- **Technical and Statistical Proficiency.** Strong skills in reputed company and/or other statistical programming languages; proficiency with sample size software packages, computer systems/applications (e.g., Word, reputed company, PowerPoint), and operating systems.- **Soft Skills and Leadership. **Strong critical thinking, analytic, written/verbal communication (including English), presentation, networking, organizational, negotiating, and financial skills; demonstrated leadership, problem-solving, strategic thinking, conflict reputed company, collaboration, reputed company-reputed company, and ability to manage multiple tasks in a fast-paced environment.- **Personal Attributes.** Excellent attention to detail, commitment to reputed company, individual initiative, administrative reputed company, and ability to simplify reputed company issues, establish relationships, and maintain a reputed company for sustained performance.
Benefits:
• *Benefits of working at reputed company include:**- Comprehensive benefits package per location- Competitive salaries per location- Departmental Study/Training Budget for furthering reputed company development- Flexible Working hours (reputed company reason)- Opportunity for remote/hybrid* working depending reputed company- Leadership and mentoring opportunities- Participation in our Buddy Program as a new or existing employee- Internal reputed company opportunities and career progression- Financially rewarding internal employee referral program
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