Sr. Clinical Bioinformatics Data Scientist - FSP at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Clinical Research, BiotechnologyIndustries

Requirements

Ability to develop statistical methods sections of protocols and review case report forms (CRFs)
Capability to prepare analysis plans and write specifications for analysis files, tables, and figures
Skills in communicating with clients regarding study protocol or statistical analysis issues
Proficiency in communicating with study team members regarding study execution, timelines, data quality, and interpretation of results
Expertise in interpreting analyses and writing statistical sections of study reports
Accountability for controlling costs and maximizing revenue recognition
Experience providing training, guidance, and mentorship to lower level and new staff
Knowledge of Standard Operating Procedures (SOPs) for validation requirements
Ability to perform statistical team lead role on single studies or studies within a compound
Familiarity with Data Management tasks including database design, validation checks, critical data review, data issue resolutions, lock, and unblinding processes
Proficiency in authoring or performing QC review of Statistical Analysis Plans (SAPs) and shells, including complex ones under supervision
Skills in writing and maintaining programming specifications for datasets to industry standards, including derivations
Expertise in writing programming specifications and programming Tables, Listings, and Figures (TLFs), ensuring consistency and efficiency
Ability to plan and document timelines, forecast resource needs, and identify out-of-scope work
Understanding of financial aspects including budget expectations, scope of work, contract assumptions, and estimate at completion (EAC) reporting
Knowledge of Clinical Data Interchange Standards Consortium (CDISC) requirements
Capability in risk management, identifying and mitigating risks to project delivery and quality

Responsibilities

Production of High-Quality Deliverables: Complete and review complex assigned tasks with focus on accuracy, conduct validation per SOPs, check programming logs, input into Data Issues log, and resolve issues
Leadership: Perform statistical team lead role on studies, work with Project Team Lead and supervisor for on-time, high-quality, within-budget delivery; build customer relationships, drive statistical discussions, run meetings, document actions, participate in project meetings, provide progress updates, and contribute to EAC reporting
Data Management: Assist in reviewing/advising on database design, validation checks, and critical data; handle data issue resolutions; manage lock and unblinding processes with supervision
Statistical Analysis Plan (SAP) and Shells: Author or QC SAPs and shells, utilizing organizational resources like libraries, templates, and consultants
Datasets: Write and maintain programming specifications; program datasets to industry standards; handle derivations
Tables, Listings and Figures (TLFs): Write programming specifications for outputs; program TLFs efficiently using tools; check output for format/content and ensure consistency
Timelines: Plan and document timelines; forecast resource needs; suggest out-of-scope work
Financials: Share accountability for financial success of studies; control costs; maximize revenue recognition; share budget expectations; raise out-of-scope concerns
Knowledge Sharing: Train staff on operational items; mentor junior staff; support and motivate colleagues
Risk Management: Identify risks to delivery/quality; proactively avoid them and propose mitigation solutions; anticipate risks to minimize escalations
CDISC and Compound Leadership: Under supervision, perform statistical team lead on studies within a compound; prioritize and proactively gain efficiencies across protocols

Skills

Key technologies and capabilities for this role

Statistical MethodsProtocol DevelopmentCRF ReviewAnalysis PlansSAS ProgrammingData ValidationSOP ComplianceStatistical AnalysisData ManagementDatabase DesignProject LeadershipClient CommunicationTeam Mentorship

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What are the key skills required for this Sr. Clinical Bioinformatics Data Scientist role?

Key skills include developing statistical methods, programming datasets and TLFs to industry standards, authoring and QC of Statistical Analysis Plans (SAPs), data management and issue resolution, and leadership in statistical team roles.

What is the company culture or work environment like at IQVIA for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

Strong candidates have experience leading statistical teams on studies, producing high-quality deliverables with validation per SOPs, programming datasets and TLFs efficiently, and providing mentorship to junior staff.

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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