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- Statistical Programmer 2
Statistical Programmer 2
IQVIA Holdings Inc.
Primary Location: Sofia, Bulgaria
Additonal Locations: Athens, Greece,GRC; Bloemfontein, South Africa,ZAF; Casablanca, Morocco,MAR; Oeiras, Portugal,PRT; Prague, Czech Republic,CZE; Tartu, Estonia,EST; Warsaw, Poland,POL
, Real World Evidence
The vision of our Real World Evidence teams is to pioneer and lead with scientific and technical expertise, the generation and dissemination of high-quality Real World Evidence that make a true difference to patient lives, globally. Come join us on this exciting journey!
Our Real World Global Biostatistics & Statistical Programming team delivers insightful analytics for predominantly primary data collection studies, and we are increasingly supporting innovative studies such as External Comparators, Enriched Studies, and Pragmatic Trials.
We are a highly motivated global team of more than 150 employees, responsible for engaging with our clients early to help shape the statistical analysis in these various study designs; contribute to protocols and deliver results that meet their needs.
We have unique opportunities to define the way our clients develop and apply Real World Evidence for healthcare decision making, so we are looking for the best talent to join us in this effort.
We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of Real World Evidence in an evolving industry!
Job Overview:
As a , provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs.
You will plan and lead the development of project-related solutions to the full scope of statistical programming tasks.
As a lead programmer on assigned studies, you will write and maintain programming specifications datasets and program TLFs, to maximize programming efficiency with the use of biostatistical tools and assist in training and mentoring new or junior team members
Key Responsibilities:
Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution
Datasets:
Writes and maintains programming specifications datasets. Programs assigned datasets to industry standards. Handles dataset derivations and assignment
Tables, Listings and Figures (TLFs):
Programs TLFs, maximizes programming efficiency with use of biostatistical tools. Checks resulting output for format and content, and questions specification as needed.
Leadership:
Perform as lead programmer on assigned studies. Through this, works closely with the Biostatistical Team Lead and Supervisor, to deliver on time, with high quality and within budget. Tasks include but are not limited to:
Develops an efficient programming strategy utilizing available tools and creation/ maintenance of project specific macros, ensures compliance with Good Programming Practice as per SOPs.
Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions.
Actively participates in internal project team meetings, providestimely progress updates.
As a lead, will have input on estimate at completion (EAC) reporting
Timelines:
Plans and documents timelines and forecasts resource needs
Project Programming Set Up:
Programming project set up and maintenance of BIOSETUP, global tools & project macros
Programming project set up for integrated databases, with supervision
Statistical Analysis Plan (SAP) and Shells:
Performs programming review of SAP and shells, where applicable. Writes programming specifications/shells for safety outputs
Financials:
Shares accountability (with resource managers) of the financial success of their studies
Responsible for sharing budget expectations with their team.
Understands 'scope of work' and has an awareness of contract and budget assumptions
Knowledge Sharing:
Helps train staff regarding operational items and mentor’s junior staff
Risk Management:
Proposes solutions to mitigate risks.
Other CDISC requirements: Reviews Pinnacle 21 output and resolves issues. Creates or performs quality control (QC) review of define.xmls, SDTM and/ or ADaM reviewers guide (SDRG, ADRG), under supervision as needed.;
Perform lead programmer role on studies
Proposals:
Review and comment on proposals/budgets at a study level
present at bid defence meetings
Customer:
Serve as primary point of contact for customer and consult on operational topics with clients.
Requirements:
Bachelors or Masters’ in Computer Science, Mathematics or equivalent
3+ years, statistical programming experience within the Life Science industry
Experience as project lead, directly engaging clients and coordinating tasks within a programming team
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
Ability to independently lead multiple tasks and projects
Join IQVIA to see where your skills can take you
Global exposure
Variety of therapeutic areas
Collaborative and supportive team environment
Access to cutting-edge and innovative, in-house technology
Excellent career development and progression opportunities
Work-Life Balance, with a strong focus on a positive well-being
Unleash your potential!
It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world.
When you join our diverse, global team, you’ll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.
Job posted: 2023-10-16