• Job Description

  Req#: 13556

  Responsible for all aspects of project and trial strategic leadership, design, planning, communication. Supervises internal junior biostatistician, provides project team and functional support, and oversees CRO biometrics groups. Performs trial design, planning, interim and final statistical evaluations and reporting. Presents results and interpretation to internal and external audiences, including regulatory authorities. Supports due diligence and regulatory negotiation, as well as research collaboration projects.

  Responsibilities

  Position Summary:

  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, including a strong focus on Real World Evidence (RWE). The incumbent will be responsible for planning and executing a range of biostatistical activities to support Medical Affairs publications and studies, as well as clinical development studies. 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.

  This role will be onsite in Waltham, MA.

  Knowledge/Skills Needed:

  • Experience in the development of statistical plans, programming, and analyses of Phase I-IV clinical trials
  • In-depth experience of SAS and R
  • Strong analytical and problem-solving abilities, with excellent organization skills and the ability to work multiple tasks simultaneously
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on new challenges
  • Ability to work in a collaborative environment, desire to learn and improve skills
  • Ability to communicate statistical information to non-scientists, willingness to educate internal teams
  • Experience with standard statistical methods including but not limited to parametric and non-parametric analysis, Bayesian statistics, survival analyses, longitudinal data analysis, logistic regression, methods used in handling missing data, MMRM, GEE, multiple testing procedures, multivariate statistics, meta-analysis and categorical data analysis
  • Experience in collaboration with Medical Affairs, HEOR, and Epidemiology to support real-world evidence generation aligned with medical strategy and patient needs
  • Ability to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses.
  • Experience in managing statistical and programming activities of CROs
  • Experience in planning and preparation of integrated summary documents- ISE, ISS

  Basic Requirements:

  • At least 8 years of experience in pharmaceutical, biotech, and/or CRO setting
  • Ph.D. in Biostatistics, Statistics or Applied Mathematics

  Preferred Requirements:

  • Ability to understand and develop statistical and patient-based models, using the latest tools and methodologies
  • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data
  • Strong statistical experience in clinical research and drug development
  • Experience in US and/or Non-US submissions
  • Strong communication and interpersonal skills; ability to interact with cross-functional teams

  Travel Expectations:

  • Overnight travel ~10%

• About the company

  Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology.

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