Sr Biostatistician at IQVIA

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, HealthcareIndustries

Requirements

Knowledge of Standard Operating Procedures (SOPs) for validation and task execution
Proficiency in statistical programming for datasets, TLFs, and analysis outputs to industry standards
Experience authoring or QC reviewing Statistical Analysis Plans (SAPs) and shells, including complex methods
Understanding of data management, including database design, validation checks, critical data, and issue resolution
Leadership skills to serve as statistical team lead on studies or within compounds (under supervision if needed)
Familiarity with CDISC standards and requirements
Ability to control costs, manage budgets, maximize revenue recognition, and assess scope of work
Capability to provide training, guidance, mentorship, and knowledge sharing to junior staff

Responsibilities

Develop statistical methods sections of protocols and review case report forms (CRFs)
Prepare analysis plans and write specifications for analysis files, tables, and figures
Communicate with clients regarding study protocol or statistical analysis issues
Communicate with study team members regarding study execution, timelines, data quality, and results interpretation
Interpret analyses and write statistical sections of study reports
Control costs and maximize revenue recognition for assigned studies
Provide training, guidance, and mentorship to lower level and new staff
Produce high-quality deliverables by completing and reviewing complex tasks, performing validations per SOPs, checking programming logs, and resolving data issues
Perform statistical team lead role on single studies or within compounds, collaborating with project leads, running meetings, providing updates, and contributing to EAC reporting
Build and maintain effective customer relationships, drive statistical discussions, and promote efficient communication
Assist data management staff with database design, validation checks, critical data, issue resolutions, database lock, and unblinding processes
Author or perform QC review of SAPs and shells, utilizing organizational libraries, templates, and consultants
Write and maintain programming specifications; program assigned datasets, including derivations
Write programming specifications for TLFs, program outputs, maximize efficiency with tools, check format/content, and ensure consistency
Plan and document timelines, forecast resource needs, and identify out-of-scope work
Share accountability for financial success of studies, communicate budget expectations, and raise scope concerns
Train staff on operational items, mentor juniors, and provide colleague support/motivation
Identify risks to project delivery/quality, proactively mitigate them, and propose solutions to avoid escalations

Skills

Biostatistics

Statistical Methods

Protocol Development

CRF Review

Analysis Plans

Statistical Programming

Data Validation

Data Management

SOP Compliance

Team Leadership

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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