Sr Dir, Biostatistics

AlkermesWaltham, MA
$274,820 - $293,881Hybrid

About The Position

In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting drug development activities and decision-making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements. Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

Requirements

  • Proven experience in strategic input into clinical development plans.
  • Familiarity with regulatory standards and requirements.

Responsibilities

  • Supporting drug development activities and decision-making encompassing Phase I-IV studies.
  • Guidance on designing studies.
  • Guidance on selecting appropriate and innovative statistical methods.
  • Guidance on analyses, interpretation, and reporting of study results.
  • Providing strategic input into clinical development plans.
  • Ensuring familiarity with regulatory standards and requirements.
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