Manager/Associate Director Biostatistics, Oncology
Waltham, MA 
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Posted 29 days ago
Job Description

Manager/Associate Director, Biostatistics in Oncology

Alkermes Overview

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Position Summary:

The Manager or Associate Director of Biostatistics will support 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.

Duties and Responsibilities:

  • Work with a group of biostatisticians to develop and execute statistical design, and analyses for clinical trials focuses on Oncology using appropriate and innovative statistical methods
  • Effectively interact with members in other functions including medical, regulatory, safety, clinical operation, clinical pharmacology, and translational medicine to ensure optimized clinical development in accordance with corporate objective
  • Provide statistical input to project team and senior management.
  • Provide statistical input and content in support of regulatory interactions and submissions- briefing books, and integrated summary documents.
  • Provide guidelines and standards to CROs and internal programing team to ensure quality of deliverables
  • Participate in department initiatives and research forums

Basic Requirements for Manager:

  • M.S. in Statistics or Biostatistics
  • 2+ years of clinical research and drug development experience

Basic Requirements for Associate Director:

  • Ph.D. in Statistics or Biostatistics
  • 5+ years of clinical research and drug development experience

Preferred Requirements:

  • Recent experience working in the field of Oncology is a plus
  • Experience with standard statistical methodologies and the development of statistical analysis plan
  • In-depth knowledge of SAS, R, or other statistical packages
  • knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management
  • Experience of interactions with regulatory agencies- US and Non-US is a plus
  • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
  • Strong communication and interpersonal skills; ability to interact with cross-functional teams
  • Flexible to changing priorities, detail-oriented, works well under pressure
  • Ability to communicate statistical information to non-scientists, willingness to educate internal team

Travel Expectations:

Travel domestic and international- up to 5%

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, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by 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.

#LI-HB1

Experience Level:
Mid-Senior Level

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.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Master's Degree
Required Experience
2+ years
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