Director, Biostatistics

Society for Conservation Biology; Bridgewater (MA); On-site; USD 179,000 - 251,000; Full time

Job summary

A leading company in biopharmaceuticals is seeking a Director of Biostatistics. This senior role involves providing statistical leadership throughout the drug development process, interacting with regulatory agencies, and leading innovative statistical activities. Candidates should have a Ph.D. in Statistics or Biostatistics and extensive pharmaceutical experience.

Benefits

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)

Qualifications

• More than 8 years of pharmaceutical experience.
• Strong knowledge of pharmaceutical environment.

Responsibilities

• Lead statistical design, analysis, and reporting of clinical trials.
• Manage timelines and oversee quality of statistical analyses.

Skills

Project Management

Interpersonal Skills

Communication Skills

Education

Ph.D in Statistics or Biostatistics

Job description

View more categories View less categories Sector Academic / Research ,Consultancy/Private Sector Field Conservation science Discipline Statistics Job Level Senior level Salary Type Salary Employment Type Full time

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 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

Salary Range
179000-250800
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 at [e-mail] 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.

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

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