Associate Director, Biostatistics

BeOne Medicines; United States; On-site; USD 163,000 - 213,000; Full time

Job summary

BeOne Medicines is seeking an experienced statistician to support hematology studies and lead SAPs and analysis plans for clinical trial reports. You will interact with cross-functional teams and contribute to regulatory submissions.

The role requires advanced statistical expertise, strong communication, and the ability to work independently in a fast-paced environment; oncology experience is a plus. Travel not required.

Qualifications

• PhD in Statistics or related field with 5+ years of experience, or MS with 8+ years.
• Experience in clinical drug development, oncology preferred.

Responsibilities

• Develop SAPs and study protocols; determine appropriate statistical methods.
• Collaborate with programming to meet analysis requirements and regulatory standards.
• Analyze trial data and interpret results to meet study objectives.
• Prepare reports to communicate trial results to the project team.
• Respond to queries from monitors, regulators, and investigators.
• Explore innovative statistical methods for trial development.

Skills

Statistical analysis

Clinical trials experience

Regulatory guidance

Team collaboration

Education

PhD in Statistics

MS in related field

Tools

SAS

R

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

Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. Provides content for manuscripts / presentations and provides statistical support in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical projects.

Essential Duties & Responsibilities

• Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology for data analysis.
• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Applies and implements basic and complex techniques to these analyses under supervision.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• 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.

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: Not required.

Education Required

A minimum of a PhD in Statistics or related field with 5+ years of experience, or a Master’s degree with a minimum of 8 years of experience in clinical drug development is required.

Global Competencies

• 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: $162,600.00 - $212,600.00 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 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
• 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].