Senior Statistical Programmer at IQVIA

Warsaw, Masovian Voivodeship, Poland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

BSc in Computer Science, Mathematics, Statistics, or related area with relevant experience
At least 5+ years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software
In-depth understanding of clinical programming and/or statistical programming processes and standards
In-depth understanding of regulatory requirements relevant to statistical programming

Responsibilities

Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings, and Analysis Submission content
Collaborates with study teams to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml)
Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data
Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO
Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format
Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group
Works closely with clinical study teams to plans and executes activities to ensure project timelines are met with high quality deliverables
Collaborates with CR&D staff regarding data analysis requests
Performs additional statistical analyses including but not limited to:
Support responses to regulatory agencies
Generate integrated summary of safety and efficacy
Support publications and presentations
Support planning and reporting of clinical trials via exploratory analyses of available data
Replicate CRO and CSL statistician analyses for QCP
Provides leadership and hands-on support in the development and maintenance of the statistical programming capabilities required to meet regulatory obligations
Works closely with the Associate Director, Director, and Statistical Programmers to build internal programming tools
Reviews datasets in submission-ready standard format (ADaM), tables, figures, listings, and submission packages
Provides expertise in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for all requested analyses

Skills

SAS

ADaM

SDTM

CDISC

define.xml

TFL

Statistical Programming

Clinical Data Analysis

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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