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BeOne

Global oncology therapeutics discovery, development, manufacturing

Associate Director - Biostatistics

Quantitative Biology & BiostatisticsPosted on Nov 9
Full-timeRemote in USARemote

About the Job

Requirements

  • A PhD in Statistics or a related field with at least five years of experience, or a Master's degree with at least eight years of experience in clinical drug development, is required.
  • Experience with clinical trials and knowledge of regulatory guidance are required.
  • Demonstrated written and oral communication skills are required.
  • Ability to work within a team and work independently is required.
  • Interdependent and analytical thinking skills, the ability to build strategic working relationships, and good decision-making capability are required.

Responsibilities

  • Work with cross-functional study and project teams supporting hematology studies, interacting with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Scientists to review data and develop and implement the statistical analysis plan for the clinical study report and other health authority submission documents.
  • Provide content for manuscripts and presentations, provide statistical support in designing and analyzing clinical trials, and coordinate statistical activities for clinical projects.
  • Develop or assist in developing study protocols and statistical analysis plans, and determine appropriate statistical methodology for data analysis.
  • Participate in database design meetings to ensure the data evaluated are high quality and satisfy analysis requirements.
  • Collaborate with statistical programming staff to ensure programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
  • Analyze data and interpret clinical trial results to meet study protocol objectives, applying and implementing basic and complex techniques under supervision.
  • Prepare oral and written reports to communicate clinical trial results to the project team.
  • Respond to queries about study design, analysis, and interpretation from clinical monitors, regulatory agencies, and investigators.
  • Participate in research activities for innovative statistical methods and applications in clinical trial development.

Desired Qualifications

  • Knowledge of SAS and/or R is strongly desirable.
  • Oncology experience is preferred but not required.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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