Associate Director, Biostatistics

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The position will work with the Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in designing clinical trials and developing the statistical analysis plan, facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts. This position needs knowledge of clinical trial design concepts, in-depth knowledge of all phases of the drug development process and demonstrated skills in the planning, analysis and reporting of clinical trials.

The position can be remote, with preference for the selected candidate to be near one of the BeOne offices in California, Massachusetts, Maryland, or New Jersey.

Essential Duties & Responsibilities:

• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development.
• Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
• Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
• Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Management team, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Involved in research activities for innovative statistical methods and applications in clinical trial development.

Computer Skills: Knowledge of SAS and/or R is strongly desirable

Education Required:

A minimum of a PhD in Statistics or related field with 4+ years of experience, or a Master’s degree with a minimum of 6+ years of experience in clinical drug development is required.

Other Qualifications: Experiences with clinical trials and knowledge of regulatory guidance are

required. Oncology experience is preferred but not required. Demonstrated written and oral

communication skills and ability to work within a team and work independently are required. Other

important requirements include interdependent/analytic thinking skills, building strategic working

relationships, and good decision-making capability.

Travel: <10%

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.