Senior Biostatistician at IQVIA

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Ability to prepare analysis plans and write detailed specifications for analysis files, tables, listings, and figures
Proficiency in interpreting analyses and writing statistical sections of study reports
Experience providing training, guidance, and mentorship to lower-level and new staff
Knowledge of Standard Operating Procedures (SOPs) for validation requirements
Skills in checking programming logs for cleanliness and correct data processing
Capability to perform statistical team lead role on single studies or studies within a compound
Ability to build and maintain effective customer relationships and drive statistical discussions
Experience running meetings, documenting actions, and providing progress updates
Familiarity with data management, including database design, validation checks, critical data review, and issue resolutions
Expertise in handling database lock and unblinding processes
Proficiency in authoring or performing QC review of Statistical Analysis Plans (SAPs) and shells, including complex ones
Skills in writing and maintaining programming specifications for datasets to industry standards
Ability to program datasets, derivations, and assignments
Experience writing programming specifications and programming Tables, Listings, and Figures (TLFs), ensuring consistency and efficiency
Competence in planning timelines, forecasting resources, and identifying out-of-scope work
Understanding of financial accountability, cost control, budget expectations, scope of work, and contract assumptions
Ability to train staff, mentor juniors, and support colleagues
Skills in risk identification, mitigation, and proactive avoidance
Knowledge of Clinical Data Interchange Standards Consortium (CDISC) requirements
Experience assisting with protocol development, sample size calculations, and review of protocols and case report forms (CRFs)
Ability to author or QC the statistical section of protocols

Responsibilities

Produce high-quality deliverables by completing and reviewing complex tasks with accuracy, conducting validations per SOPs, and resolving data issues
Perform statistical team lead role on studies, working with project teams to deliver on time, within budget, and with high quality
Build customer relationships, provide statistical support/guidance, run meetings, document actions, and participate in project team meetings
Provide input on estimate at completion (EAC) reporting as a lead
Assist data management staff with database design, validation checks, critical data, and issue resolutions; handle lock/unblinding
Author or QC SAPs and shells, utilizing organizational resources for complex methods
Write and maintain programming specifications; program datasets to industry standards
Write specifications and program TLFs, maximize efficiency, check output, and ensure consistency
Plan and document timelines, forecast resources, and flag out-of-scope work
Share accountability for financial success, control costs, maximize revenue, communicate budget expectations, and raise scope concerns
Train staff on operational items, mentor juniors, and motivate colleagues
Identify and mitigate project risks proactively
Under supervision, lead statistical teams on studies within a compound, prioritizing efficiencies across protocols
Assist with study startup, including protocol development, sample size calculations, and CRF/protocol reviews
Author or QC statistical sections of protocols, using organizational resources

Skills

SAS

Statistical Analysis

Analysis Plans

SAP

Data Management

Programming Specifications

QC Review

Validation

SOPs

Datasets

Tables Listings Figures

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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