Director, Biostatistics

Location
Bridgewater, NJ
Posted
Aug 15, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Company Description

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.

Overview

The Director of Biostatistics is responsible for leading a product line through the entire development process by providing input into the drug development plan, researching and leading the design, analysis, and reporting of clinical trials. This position involves interaction with Contract Research Organizations (CROs), as well as Clinical Development, Medical Affairs, Data Management, Clinical Scientists and Regulatory Affairs in designing and analyzing clinical trials and coordinating the statistical activities for drug development projects. This position provides statistical support to publications by performing statistical analyses of clinical trial data.

Responsibilities

    • Position will be lead statistician on a product line.
    • Position represents Insmed at meetings with regulatory authorities.
    • Adept in the development of study design, statistical analysis, and the interpretation of results.
    • Position leads, plans, and executes the statistical strategies for regulatory submissions and regulatory interactions with minimal guidance needed from senior level Statistical Management.
    • This position contributes to drug development plans and contributes to documents submitted to Health Authorities globally.
    • This position leads programmers and statisticians in preparing analysis files and performing statistical analyses.
    • This position interacts with study teams, as well as statisticians and programmers at CROs.
    • Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
    • Provides input to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.
    • Mentors less experienced statisticians.
    • Able to operate independently and make key business decisions.
    • Thinks strategically and plans for future business need on assigned product line. 

Qualifications

    • MS or PhD in Statistics or Biostatistics required.
    • Minimum of 10 years of clinical trial experience (PhD) or minimum of 12 years of clinical trial experience (MS) in a biotech, pharmaceutical, or CRO setting.
    • Demonstrated experience in leading and managing project teams.
    • Must have excellent communication skills (verbal and written).
    • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
    • Strong knowledge of statistical methodologies applicable to Clinical Research.
    • Strong knowledge of clinical research and medical terminology for study design and results interpretation.
    • Strong analytical and problem-solving skills.
    • Able to identify and investigate causality independently and formulate potential solutions.
    • Able to prioritize multiple tasks, manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.
    • Knowledge of statistical ethics, guidelines, and principals established by US Food and Drug Administration (FDA), European Medicines Agency (EMA), International Conference on Harmonisation (ICH), and the American Statistical Association.
    • Good programming skills in SAS and working knowledge of software such as nQuery, R, etc.
    • Able to operate independently and make key business decisions.
    • Thinks strategically and plans for future business need on assigned product line.
    • May require Domestic and/or International travel (some overnight), 10% of work time maximum.
    • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies. 
    • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Information

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.