Associate Director, Biostatistics
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
- This position reports directly to the Senior Director of Biostatistics.
- This is a non-supervisory position.
The Associate Director of Biostatistics is responsible for the statistical design, analysis, and reporting of clinical trials. This position involves interaction with Contract Research Organizations (CROs), as well as Medical Affairs, Data Management, Clinical Scientists and Regulatory Affairs in designing and analyzing clinical trials and coordinating the statistical activities for drug development projects. Additionally, this position provides statistical support to publications by performing statistical analyses of clinical trial data.
- Involved in early development planning of development strategies to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs
- Performs sample size estimation for clinical trials
- Identifies appropriate statistical methodology needed to meet trial objectives
- Participates in meetings to identify data collection instruments and database design requirements to ensure that the data evaluated are free of bias, contain maximum information, and satisfy analysis requirements
- Contributes to decision making on design and data collection ensuring alignment with trial objectives
- Analyzes data and interprets results for publications
- Performs peer review of protocol, statistical analysis plan, trial report, and other major deliverables including publications
- Prepares reports to effectively communicate results of clinical trials to the project team, senior management, regulatory agencies and/or individual investigators
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators
- Oversees statistics-related activities of CROs to ensure that timelines are followed
- Conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods, and develops new methods
- Keeps management informed on important scientific/statistical issues that may arise, in a timely manner
- MS or PhD in Statistics or Biostatistics required.
- With MS, minimum of 10 years of clinical trial experience in a biotech, pharmaceutical, or CRO setting. With PhD, candidates with minimum of 7 years of experience will be considered.
- Experience and knowledge in the design, statistical planning, data analysis, and reporting of clinical trials is required
- Hands-on knowledge of SAS is a must; R is optional
- Working knowledge of statistical regulatory requirements / regulations
- Excellent communication skills (verbal and written), highly organized, and have strong attention to detail, clarity, accuracy and conciseness
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Ability to work in a team environment is critical
- May require Domestic and/or International travel, 10% of work time maximum
- Must successfully exhibit Insmed’s five (5) values of: Collaboration, Accountability, Passion, Respect and Integrity
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local 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.
Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.