• Principal Biostatistician FSP - Medical Affairs

    Cytel (Indianapolis, IN)


    As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses.

    You will contribute by:

    + Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.

    + Writes the statistical sections of study protocols, while consulting with internal and external experts.

    + Contributes to or prepares statistical analysis plans.

    + Collaborates with Data Management and Medical Research on design of eCRFs.

    + Provides statistical guidance on conduct of ongoing studies.

    + Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs

    + Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.

    + Contributes to scientific articles, summarizing data collected in Alnylam studies.

    + Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.

    + Reviews abstracts, manuscripts for publications and presentations.

    What we’re looking for:

    + PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.

    + Excellent written and oral communication and presentation skills.

    + Extensive experience programming in SAS.

    + Extensive experiences working on data analysis with clinical studies database

    + Experience working on post-approval observational and clinical studies.

    + Understanding of ICH GCP as well as general knowledge of industry practices and standards.

    + Experiences in R programming language and other statistical software.

    + Experience with CDISC, including SDTM, ADaM, CDASH.

     

    Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.