BeiGene, Ltd.

Associate Director, Biostatistics

BeiGene, Ltd.$162K — $212K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • PhD in Statistics or related field with 5+ years experience, or Master's degree with 8+ years experience in clinical drug development.
  • Strong knowledge of SAS and/or R programming.
  • Experience with clinical trials and understanding of regulatory compliance are mandatory.
  • Excellent verbal and written communication skills are essential.
  • Proven ability to work both collaboratively in teams and independently.
  • Strong analytical thinking skills and good decision-making abilities.

Responsibilities

  • Develop or assist in creating study protocols and statistical analysis plans (SAPs).
  • Participate in database design to ensure data quality for analysis.
  • Collaborate with programming staff to ensure analytical programs meet standards and regulatory requirements.
  • Analyze and interpret clinical trial data according to study protocols.
  • Prepare and present reports on clinical trial results to project teams.
  • Respond to inquiries regarding study design, analysis, and interpretation from regulatory agents and investigators.
  • Engage in research for innovative statistical methods in clinical trial development.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan with company matching contributions.
  • Flexible spending accounts (FSA) and health savings accounts (HSA).
  • Life insurance and paid time off (PTO).
  • Wellness program initiatives and support.
  • Equity ownership opportunities through stock options and the Employee Stock Purchase Plan.
Full Job Description

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.

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, and Wellness.

About BeiGene, Ltd.

BeiGene, Ltd. is a biotechnology company that develops and commercializes innovative cancer treatments. The company was founded in 2010 and is headquartered in George Town, Grand Cayman. BeiGene's portfolio includes several drug candidates that target cancer cells and the tumor microenvironment. The company's lead product, Brukinsa, is a treatment for mantle cell lymphoma that has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). BeiGene also has partnerships with several pharmaceutical companies, including Amgen, Merck, and Novartis.
Learn more about BeiGene, Ltd.
Size
8,300 employees
Market Cap
$22.2 billion
Industry
Net Income
-$1.5 billion
Founded
2010
5 Year Trend
+305.7%
Revenue
$308.8 million
NASDAQ

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