Sr Director, Biostatistics

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
Named Science’s Top Employer in 2021, 2022, and 2023
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 were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.
Overview
The Senior Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and expertise for a program with multiple indications 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.
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Provide leadership, guidance and strategic inputs as the program lead and accountable for all statistical aspects of projects within the program, including regulatory submission and regulatory interactions.
• Ensure strategic alignment and consistency in statistical contributions within the program.
• Manage and mentor a team of statisticians, defining team member priorities, conducting performance reviews and identifying development areas. Responsibility for resource planning and allocation.
• Foster productive collaboration across Biometrics and cross-functionally, while effectively communicating with senior executives.
• Act as the statistical representative in key cross-functional initiatives.
• Lead key departmental initiatives at advancing our statistical capabilities and contributing to organizational growth.
  

Qualifications

• A Ph.D. in Statistics or Biostatistics with more than 12 years of pharmaceutical experience
• Demonstrated strong knowledge of pharmaceutical environment, including experience with multi-phase development.
• Profound expertise and in-depth understanding of advanced statistical concepts and techniques applicable to Clinical Research
• Broad experience in non-clinical efficacy and safety studies is highly desired
• Previous experience in managing multiple direct reports
• Strong project management, interpersonal and communication skills
• A track record of successful contribution to submission dossiers (IND, CTD) and interactions with regulatory agencies or other external stakeholders
• Experience with multiple (s)NDAs, and MAA’s
• Outstanding ability to influence and to contribute to the advancement of innovative statistical methodology
  

Travel Requirements
Approximately 10% Domestic and/or International travel required
Salary Range
Insmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $210,000.00 to $290,000.00 per 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
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).
  

Additional U.s. Benefits

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer
  

Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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 until the position is filled.