Principal Statistical Programmer 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

Pharmaceutical, CROIndustries

Requirements

Minimum 7+ years of experience in Statistical Programming in pharmaceutical or CRO/Pharma industry (Oncology, Immunology, IDV, EDCP therapeutic areas preferred)
Expertise in R programming, SAS Base, SAS/STAT, SAS Graph, SAS Macros, SAS/ACCESS, SAS/ODS, SAS/SQL
Excellent knowledge of CDISC standards (SDTM and ADaM implementation)
Thorough understanding of relational database components and theory
Strong understanding of clinical trial data, data manipulations, analysis, and reporting
Good understanding of ICH E6, ICH E3, ICH E8, ICH E9, GCP, and clinical research processes
Experience as technical team lead engaging clients and coordinating programming teams
Advanced knowledge of statistics, programming, and clinical drug development processes
Excellent verbal and written communication, organizational, interpersonal, and leadership skills
Ability to independently manage multiple tasks/projects, delegate work, lead teams, solve complex problems, and establish effective relationships
Excellent accuracy, attention to detail, and ability to plan, organize, and prioritize activities

Responsibilities

Plan, coordinate, perform, test, and document statistical programs for creating tables, figures, listings, analysis datasets, derived datasets, and transfer files for complex studies
Program quality control checks for source data and report data issues periodically
Interpret project-level requirements and develop programming specifications for complex studies
Provide advanced technical expertise to internal/external clients and bring solutions to SP teams and department for complex studies
Fulfill project responsibilities as technical team lead for single complex studies or groups of studies
Directly communicate with internal/client statisticians and clinical team members to ensure understanding of requirements and timelines
Estimate programming scope of work, manage resource assignments, communicate project status, and negotiate/re-negotiate project timelines

Skills

R programming

SAS Base

SAS/STAT

SAS Graph

SAS Macros

CDISC SDTM

CDISC ADaM

relational databases

clinical trial data

data manipulation

ICH E6

ICH E3

ICH E8

ICH E9

GCP

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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