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Director, Biostatistics

Location: Cambridge
Posted on: February 25, 2021

Job Description:

Career Opportunities with Seres Therapeutics, Inc. A great place to work. Careers At Seres Therapeutics, Inc. Even if you don't see a job that's a fit, but you're excited by what Seres is doing and want to be a part of it, we'd appreciate hearing from you and will keep you in mind for a future opportunity.--Click here --to submit your resume.-- Why Seres Therapeutics
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres Therapeutics is a member of the Flagship Pioneering family of companies. Position Summary
At Seres, we're leading the microbiome revolution - and our most revolutionary asset is our team. Their courage and deep commitment are what drives us on our mission to transform the lives of patients worldwide with revolutionary microbiome therapeutics Reporting to the Chief Medical Officer, you will provide statistical leadership and expertise in support of the clinical development of Seres' products. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. The Senior Director, Biostatistics will participate in regulatory interactions and submissions to the FDA and other regulatory agencies and contribute to the biometrics effort across the different programs to identify, develop and implement departmental standards, applications, processes, and training. 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
  • Provide guidance and direct input in addressing any statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings
  • Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed
  • Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes
  • Develops statistical analysis plans for studies, performs complicated statistical analyses, and oversees the generation of tables, listings and figures for study reports and manuscripts
  • Demonstrates proficiency with SAS statistical procedures, familiarity with specialized statistical software (e.g.,R, S-PLUS, EaSt)
  • Lead in developing department standards and research in advanced statistical methodologies What You'll Bring
    • PHD in Biostatistics or Statistics with 10+ years of pharmaceutical, biotechnology or equivalent experience, or Masters in Biostatistics or Statistics with 14+ years of pharmaceutical, biotechnology or equivalent experience
    • Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it in designing data acquisition trials, assessing results, analyzing trend
    • Led NDA/BLA/MAA activities from a statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections
    • 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
    • Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g. FDA, ICH and EMEA)
    • Experience in oversight/management of biostatistical services provided by CROs and/or contractors Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

Keywords: SERES THERAPEUTICS, INC., Cambridge , Director, Biostatistics, Executive , Cambridge, Massachusetts

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