Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Associate Director, Biostatistics

Department: Medical
Location: Cambridge, MA

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases.  We are pioneers and explorers, charting a new course.  If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

As Associate Director of Biostatistics, you will provide statistical leadership and expertise in support of the clinical development of Seres' products.  You will be expected to contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission and integrated safety and efficacy reporting.  As an individual contributor, you will directly support pivotal trials within, SERES pipeline.

What You’ll Do

  • Apply complex and innovative statistical approaches to your work (e.g. modeling and simulation, adaptive design/Bayesian statistics)
  • Provide interpretive and analytical publication support, safety surveillance, pharmaco-economic initiatives and statistical consulting advice to other functions as needed
  • Participate in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions

What You’ll Bring

  • PHD in Biostatistics or Statistics with 6+ years of pharmaceutical, biotechnology or equivalent experience, or Masters in Biostatistics or Statistics with 8-10+ years of pharmaceutical, biotechnology or equivalent experience
  • Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it all to phases of clinical trials
  • Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing
  • Prior experience communicating with and presenting to the US FDA and European Regulatory Authorities
  • Prior experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submission
  • Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g. FDA, ICH and EMEA)

You May Also Bring

  • Experience in oversight/management of biostatistical services provided by CROs and/or contractors
  • Ability to prioritize and effectively manage several projects simultaneously

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome.  Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome.  Current candidates span infectious, metabolic, and inflammatory diseases.  For more information, please visit http://serestherapeutics.com/

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