Assoc Director, Biostatistics

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 Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line. This role leads the protocol statistical section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or several compounds in development. Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of statistical design, study setup, execution, analysis and reporting of clinicals. Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams. Undertake new and highly complex issues requiring advanced analytical thought with minimal supervision Support global submission deliverables as needed including responses to health authority queries, advisory committee meeting preparation, etc Provide statistical support for the Biometrics Department's infrastructure needs Qualifications MS in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience or a PhD in Statistics/Biostatistics with more than 6 years of' relavant pharmaceutical experience Knowledge of pharmaceutical environment and regulatory requirements Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research Excellent project management, interpersonal and communication skills Experience with NDAs, and MAA's is highly desired Ability to influence and to contribute to the advancement of innovative statistical methodology Travel Requirements May require Domestic and/or International travel, 10% of work time maximum Salary Range $147,000 - $206,333 a year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work, regionally based Competitive compensation package including bonus Stock options and RSU awards Employee Stock Purchase Plan (ESPP) Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS: 401(k) plan with company match Medical, dental, and vision plans Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity insurance Employee Assistance Program (EAP) Mental Health on-line digital resource Well-being reimbursement Paid leave benefits for new parents Paid time off to volunteer On-site, no-cost fitness center at our U.S. headquarters Additional Information Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewardsinsmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Applications are accepted for 5 calendar days from the date posted or until the position is filled.