Senior Manager, Biostatistics

BeOne Medicines Ltd.; United States; On-site; USD 155,000 - 200,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Manager, Biostatistics to lead statistical analyses for clinical trials and contribute to study design and analysis plans.

You will mentor teams across data management, SAS programming, pharmacology, and medical writing while ensuring high-quality deliverables within timelines. The role requires a PhD or equivalent in statistics/biostatistics with several years of experience, strong collaboration skills, and expertise in regulatory statistical standards.

Qualifications

• PhD or equivalent degree in statistics/biostatistics with a minimum of 3+ years relevant work experience.
• Master’s degree with a minimum of 5+ years relevant work experience.

Responsibilities

• Serve as trial statistician and work in the cross-functional team for study planning and execution, and reporting.
• Develop individual protocol/SAP and determine appropriate statistical methodology.
• Participate in database design meetings to ensure data quality for analysis requirements.
• Collaborate with statistical programming staff to ensure programs meet analysis and external requirements; provide tables, listings and graphs.
• Analyze data and interpret results from clinical trials and apply statistical techniques.
• Prepare oral and written reports to communicate results to the project team and stakeholders.
• Provide statistical input in planning/conduct of clinical trials with internal and external teams.
• Identify and resolve technical, quality, and timeline issues; contribute to methodological development.

Skills

Biostatistics

Clinical trial design

Statistical analysis

SAS programming

Vendor management

Education

PhD in statistics/biostatistics

MS in statistics/biostatistics

Tools

SAS

Job description

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 Senior Manager, Biostatistics will perform scientific statistical analyses in support of clinical trials with guidance and mentoring on new and complex issues. The position will work with the clinical and regulatory team 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. The individual will interface with clinical therapeutic area members, SAS programming, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions. This position will also participate in managing vendors to ensure quality of all deliverables and adherence to requirements/timeline. 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.

Essential Functions Of The Job

• Responsibilities will include, but are not limited to, the following:
• Serve as trial statistician and work in the cross-functional team for study planning and execution, and reporting.
• Develop individual protocol/SAP and determine appropriate statistical methodology.
• Participate in database design meetings to ensure that the data collected are in high quality and satisfy analysis requirements.
• Collaborate with the statistical programming staff to ensure that all programs meet analysis and external requirements. Work with programmers to provide tables, listings and graphs, including ad hoc validation.
• Analyze data and interpret results from clinical trials to meet objective of the study protocol. Independently apply and implement basic and complex statistical techniques to these analyses. Conduct ad hoc analyses if applicable
• Prepare oral and written reports to effectively communicate results of clinical trials to the project team and corresponding parties.
• Provide statistical input through the planning and conduct of clinical trials with departments with BeiGene as well as with external vendor.
• Make recommendations or resolve technical, quality, and timeline issues.
• Participate in innovative statistical methodology development that stemmed from project questions.
• Provides stat support in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests.
• Identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of studies, proposes solutions and carries them out.
• Serves as statistical representative in the cross-functional teams for all the project involved.

Supervisory Responsibilities

• No

Education Required

PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3+ years relevant work experience

Master’s degree with a minimum of 5+ years relevant work experience

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

Salary Range: $155,000.00 - $200,000.00 annually

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 an 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 [e-mail].