Director for RW DC Bios at IQVIA

Tokyo, Japan

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Expertise in Biostatistics and Statistical Programming
Ability to manage direct personnel reports (Manager to Associate Director level)
Knowledge of clinical trial methodology and regulatory requirements
Experience with statistical consulting, protocol development/review, analysis plans, and clinical/statistical reports
Familiarity with FDA interactions and representing clients at regulatory meetings
Understanding of financial management, budgeting, and revenue maximization
Compliance with organizational policies, SOPs, and regulations

Responsibilities

Manage department of Biostatistics and Statistical Programming staff to meet productivity targets (project allocations, utilization, output)
Serve as site head or functional head within a site
Participate in sales meetings and oversee departmental proposal preparation
Monitor budget and scope of projects to maximize realization
Ensure staff contribute to intra- and interdepartmental process improvements for "best practices"
Provide professional development and training to staff
Act as Biostatistical resource, ensuring scientific integrity in statistical methodology for clinical trials
Provide statistical direction, technical oversight, or consultancy on major or complex projects
Represent clients at FDA or other scientific meetings
Ensure high quality and timeliness of deliverables and expert review processes
Serve as statistical consultant internally and across departments
Maintain knowledge of developments in Biostatistics, clinical trials, and regulations
Participate in Data and Safety Monitoring Committees, research, teaching, presentations, and publications as approved
Lead biostatistician on major projects (protocols, analysis plans, reports, NDAs)
Provide advanced technical expertise to clients
Manage staff: planning/assigning/directing work, performance appraisals, development, rewards/discipline, employee relations, compliance
Approve HR actions and oversee project-level staff work and resource strategy
Ensure compliance with strategy/initiatives, implement them, collect feedback, provide training
Control costs and maximize revenue at client/service group level
Participate in monthly project reviews and operations meetings
Define overall strategy and initiatives for service group or client

Skills

Key technologies and capabilities for this role

BiostatisticsStatistical ProgrammingClinical TrialsStatistical MethodologyRegulatory RequirementsFDA RepresentationData AnalysisProject ManagementStaff LeadershipProcess Improvement

Questions & Answers

Common questions about this position

What is the salary for the Director for RW DC Bios position?

This information is not specified in the job description.

Is this a remote position or what is the location requirement?

This information is not specified in the job description.

What are the key skills required for this role?

The role requires expertise in biostatistics and statistical programming, knowledge of clinical trial methodology and regulatory requirements, and advanced statistical analysis skills for complex projects.

What does the team structure look like for this position?

The role involves managing a department of Biostatistics and Statistical Programming staff, with direct reports typically at Manager to Associate Director level.

What makes a strong candidate for this Director position?

Strong candidates will have leadership experience in managing biostatistics teams, expertise in ensuring high-quality deliverables and statistical integrity in clinical trials, and the ability to provide technical oversight on complex projects while representing clients at regulatory meetings.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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