Director Biostatistics at Insmed Incorporated in Bridgewater, New Jersey

Job Description:

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




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 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



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 10 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 applicable to Clinical Research


• 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 NDAs, and MAA's is highly desired


• Ability to influence and to contribute to the advancement of innovative statistical methodology

Qualifications

• A Ph.D in Statistics or Biostatistics with more than 10 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 applicable to Clinical Research


• 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 NDAs, and MAA's is highly desired


• Ability to influence and to contribute to the advancement of innovative statistical methodology

Travel Requirements



Up to 10% travel



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 $175,000.00 to $241,667.00 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, 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 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 for 5 calendar days from the date posted or until the position is filled.


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