Director, Medical Affairs Biostatistics

Insmed; United States; Remote; USD 179,000 - 251,000; Full time

Job summary

Insmed is seeking a Director of Medical Affairs Biostatistics to provide statistical leadership in supporting evidence generation and publication strategies. The role involves overseeing statistical activities for compounds, fostering collaboration, and guiding junior statisticians, all within a dynamic Biostatistics team focused on innovative solutions for rare diseases.

Benefits

Flexible approach to work

Health benefits

Competitive compensation package

Equity Awards

Employee Stock Purchase Plan

Qualifications

• 8+ years of pharmaceutical experience required.
• Strong knowledge of multi-phase development.
• Experience in HTA and post-marketing studies preferred.

Responsibilities

• Lead statistical activities for one or more compounds.
• Accountable for statistical aspects of various studies.
• Provide technical guidance and mentorship to junior statisticians.

Skills

Advanced statistical concepts

Clinical trial data analysis

Project management

Interpersonal skills

Communication skills

Education

Ph.D. in Statistics or Biostatistics

Tools

SAS

R

SDTM datasets

ADaM datasets

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

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.

OverviewThe Director of Medical Affairs Biostatistics is a highly visible role and is responsible for the statistical leadership and expertise to collaborate closely with the Medical Affairs organization to support evidence generation and publication strategy. We are seeking an experienced and strategic statistician to join our dynamic Biometrics Medical Affairs team. Responsibilities

• Lead the Medical Affairs statistical activities for one or several compounds.
• Represent the Biostatistics team within cross-functional teams, being accountable for statistical aspects of post-marketing studies, Real-World Evidence (RWE) studies, Heath Technology Assessment (HTA) submissions and publications.
• Oversee timelines and the quality of statistical analyses conducted by both CROs or internal teams.
• Independently undertake advanced statistical methods to support medical decision-making and evidence generation across Medical Affairs activities.
• Promote collaboration across Biometrics and other cross-functional teams, ensuring effective communication and the integration of statistical expertise into key business decisions.
• Contribute to department and transversal initiatives, supporting organizational growth.
• Provide technical guidance and mentorship to junior statisticians.

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Ph.D. in Statistics or Biostatistics with over 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 applicable to clinical research.
• Strong project management, interpersonal and communication skills.
• Ability to influence and contribute to the advancement of innovative statistical methodologies.
• Hands-on experience in designing and analyzing clinical trial data, with proficiency in SDTM and ADaM datasets and statistical software such as SAS and R.
• Prior experience in HTA, RWE and post-marketing studies is higher desired.

Up to 10% travel Remote (only in corp. office for purposeful meetings) Salary Range$179,000 - $250,800 a year Compensation & Benefits

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.

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 [e-mail] 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.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.