Director, Biostatistics

Insmed Inc. • Bridgewater, NJ • 15h ago

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists. Overview The Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a product line through the entire development process. This role provides statistical input into the drug development plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads and contribute to statistical innovation activities. Responsibilities The Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a product line through the entire development process. This role provides statistical input into the drug development plan, researches and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This role also leads and contribute to statistical innovation activities.Additional representative responsibilities will include, but not necessarily be limited to, the following: Lead one or several indications corresponding to one or several compounds in development. Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of clinical development plans, studies, submission activities and regulatory interactions. Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams. Lead or contribute to statistical innovation activities including innovative design, advanced analytics, data visualization and template development. Independently undertake new and highly complex issues requiring advanced analytical thought Foster productive collaboration across Biometrics and cross-functionally, while effectively communicating with key stakeholders. Lead and contribute to departmental projects Provide technical guidance and mentoring to Junior statisticians. Qualifications A Ph.D in Statistics or Biostatistics with more than 8 years of pharmaceutical experience Strong knowledge of pharmaceutical environment and broad experience with multi-phase development. * Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applic

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