Associate Director, Biostatistics

BeiGene, Ltd.; Northern (KY); On-site; USD 163,000 - 213,000; Full time

Benefits offered by this job

Medical insurance

Dental Insurance

Vision Insurance

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness programs

Job summary

BeOne Medicines Ltd. is seeking an Associate Director of Biostatistics to lead statistical strategy for hematology studies. You will review data, develop SAPs for CSR submissions, and coordinate statistics activities across cross-functional teams, including Clinical, Regulatory, and Data Management.

The role requires a PhD in Statistics or related field with 5+ years in clinical drug development, or a Masters with 8+ years. Strong SAS/R programming and regulatory knowledge are essential.

Qualifications

• PhD in Statistics or related field with 5+ years of experience, or a Master’s degree with 8+ years in clinical drug development.
• Experience with clinical trials and knowledge of regulatory guidance.
• Oncology experience is preferred but not required.
• Demonstrated written and oral communication skills; ability to work in a team and independently.

Responsibilities

• Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology.
• Participates in database design meetings to ensure data quality and analysis readiness.
• Collaborates with statistical programming to ensure programs meet analysis requirements and regulatory guidance.
• Analyzes data and interprets results from clinical trials to meet study objectives.
• Prepares reports to communicate results to the project team and stakeholders.
• Interacts with monitors/regulators to respond to study design and analysis queries.
• Engages in research for innovative statistical methods in clinical trial development.

Job description

## Associate Director, BiostatisticsApply: Remote (US): Full time: Posted Today: R36146BeOne 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 otherhealth authority submission documents. Provides content for manuscripts / presentations and providesstatistical support in designing and analyzing clinical trials, and in coordinating the statistical activities forclinical projects.**Essential Duties & Responsibilities:*** Develops or assists development of study protocols and SAPs and determines appropriate statisticalmethodology for data analysis.* Participates in database design meetings to ensure that the data evaluated are in high quality and satisfyanalysis 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 andimplements 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 clinicalmonitors, regulatory agencies, and/or investigators.* Involved in research activities for innovative statistical methods and applications in clinical trialdevelopment.**Computer Skills:** Knowledge of SAS and/or R is strongly desirable**Other Qualifications:** Experiences with clinical trials and knowledge of regulatory guidance arerequired. Oncology experience is preferred but not required. Demonstrated written and oralcommunication skills and ability to work within a team and work independently are required. Otherimportant requirements include interdependent/analytic thinking skills, building strategic workingrelationships, 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 CompetenciesWhen 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 ClaritySalary Range: $162,600.00 - $212,600.00 annuallyBeOne 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.