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Associate Director, Biostatistics
BeOne Medicines. Work with cross-functional study/project teams supporting hematology studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in statistical analysis and methodologies for clinical trials, with strong capabilities in developing statistical analysis plans and collaborating with cross-functional teams. Proficient in SAS and/or R, with a solid understanding of regulatory guidance and clinical drug development.
Highest-signal resume keywords
PhD In Statistics Or Related FieldClinical Trials ExperienceSAS And/or R ProficiencyStatistical Analysis Plans DevelopmentRegulatory Guidance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical AnalysisData AnalysisStudy Protocol DevelopmentStatistical MethodologiesClinical Trial DesignDatabase DesignStatistical ProgrammingData ManagementClinical Study ReportsHealth Authority Submission
Soft Skills
Written Communication SkillsOral Communication SkillsTeam CollaborationAnalytic ThinkingDecision-Making Capability
Industry Keywords
Hematology StudiesOncology ExperienceCross-Functional TeamsResearch ScientistsRegulatory Agencies
About the role
Key responsibilities & impact- Work with cross-functional study/project teams supporting hematology studies
- Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Scientists
- Review data and develop and implement statistical analysis plans for clinical study reports and health authority submission documents
- Provide content for manuscripts and presentations
- Provide statistical support in designing and analyzing clinical trials
- Coordinate statistical activities for clinical projects
- Develop or assist with developing study protocols and statistical analysis plans
- Determine appropriate statistical methodologies for data analysis
- Participate in database design meetings to ensure data quality and analysis suitability
- Collaborate with statistical programming staff to ensure programs meet analysis, internal SOP, and regulatory requirements
- Analyze and interpret clinical trial data under supervision
- Prepare oral and written reports communicating clinical trial results
- Respond to study design, analysis, and interpretation queries from clinical monitors, regulatory agencies, and investigators
- Participate in research on innovative statistical methods and applications in clinical trial development
Requirements
What you’ll need- 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
- Experiences with clinical trials
- Knowledge of regulatory guidance
- Knowledge of SAS and/or R is strongly desirable
- Oncology experience is preferred but not required
- Demonstrated written and oral communication skills
- Ability to work within a team and work independently
- Interdependent/analytic thinking skills
- Ability to build strategic working relationships
- Good decision-making capability
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Voluntary Employee Stock Purchase Plan participation
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits