Biostatistician I/II at Alkermes

Company Overview:

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com .
To achieve our goals for continued growth, the new position of Biostatistician I/II was created in the Biostatistics team. This unique position offers an ambitious candidate the opportunity to contribute and learn through direct exposure to a wide spectrum of biometrics activities in support of Clinical Development, Regulatory Agency submissions, and Medical Affairs. The incumbent will be responsible for planning and executing a range of biostatistical activities to support Medical Affairs publications and submissions. These responsibilities may also include ad hoc analyses of existing databases, study design simulation, meta-analyses, and data mining. Tasks include planning, programming, and executing statistical analyses; contributing to content and review of presentations and manuscripts; and occasional instructing and reviewing third party statistical planning and analysis work.

KEY DUTIES:

  • Plan and execute a range of biostatistical activities to support Clinical Development and Medical Affairs
  • Perform study design simulation and ad hoc analyses of existing databases, meta-analyses, and data mining
  • Plan the statistical analyses, programming and execution of the analyses, instructing and reviewing third party statistical planning and analysis work
  • Contribute to content and review of presentations and manuscripts
  • Oversee third party vendors as needed

TECHNICAL SKILLS:

  • Experience with standard statistical methodologies
  • Experience in the development of statistical plans
  • Working knowledge of SAS and R
  • Experience in analyses of observational studies or clinical trial studies
  • Experience with data extraction, cleaning, and analysis

PERSONAL SKILLS:

  • Excellent analytical, problem solving, communication and organization skills
  • Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
  • Ability to work in a collaborative environment, drive to learn and improve skills
  • Ability to communicate statistical interpretation to non-scientists

MINIMUM EDUCATION AND EXPERIENCE:

  • At least 2 years’ experience in pharmaceutical, academic, or managed care setting
  • Ph.D in Biostatistics or equivalent degree
  • Ability to understand and develop statistical and models using the latest tools and methodologies
  • Strong analytical skills and demonstrated experience in gathering, analyzing, interpreting, reporting and presenting data
  • Ability to anticipate challenges and defend positions with factual information
  • Strong record of scientific publication

TRAVEL EXPECTATIONS

  • Overnight travel up to 10%

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
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