20 days old

Manager, Biostatistics

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    RD2019R1046

Manager, Statistics

Overview

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. In 2018, Alnylam received approval for our first product, the first-ever RNAi therapeutic, by the FDA in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Headquartered in Cambridge, Mass., Alnylam employs over 1,200 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work four years in a row (2015-2018) and a Great Place to Work in the U.K. and Switzerland in 2019. Please visit www.alnylam.com for more information

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The Manager Statistics is responsible for statistical activities in support of clinical trials, including: contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

Summary of Key Responsibilities

  • Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.

  • Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.

  • Contributes to or prepares statistical analysis plans.

  • Collaborates with Data management, Clinical Development, and Clinical Operations on design of eCRFs.

  • Provides statistical guidance on conduct of ongoing trials.

  • Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADS and ad hoc analysis specifications.

  • Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.

  • Contributes to scientific articles, summarizing data collected in Alnylam trials.

  • Participates in other activities and meetings to support Biostatistics and the Development Team as needed.

  • Consults with Research & Preclinical colleagues on statistical questions in their work.

  • Manages CRO statistical and programming support.

    Qualifications

  • PhD in Biostatistics, Statistics, or Equivalent with at least 3 years pharmaceutical biostatistics experience or MS with at least 5 years' of relevant experience. Title will be commensurate with experience

  • Excellent written and oral communication and presentation skills.

  • Experience programming in SAS.

  • Experience with simulations

    Desired Experience

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

  • Familiarity with R programming language and other statistical software, including EAST.

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

    Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

    #LI-MM1







  • Posted: 2019-10-31 Expires: 2019-11-29
    Sponsored by:
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    Sponsored by:
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    Manager, Biostatistics

    Alnylam Pharmaceuticals
    Cambridge, MA 02139

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