Statistical Programmer

About us:
Data Science UA
is a service company with strong data science and AI expertise. Our journey began in 2016 with the organization of the first Data Science UA conference, setting the foundation for our growth. Over the past 7 years, we have diligently fostered the largest Data Science Community in Eastern Europe, boasting a network of over 30,000 AI top engineers.

About the company:
The company is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs, and quality assurance, the company enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, the company clients realize efficiencies in cost and time, while comprehensive solutions unify the entire development process. The company partners with the world’s most influential life science and medical device companies to research, design, develop, and commercialize new healthcare technologies and treatments to advance patient care.

About the role:
We are looking for a Statistical Programmer, who will provide statistical programming support and expertise for the implementation of data models and the reporting of clinical trials.

– Bachelor’s degree or master’s degree or international equivalent in statistics, computer science, or life sciences.
– Bachelor’s degree or international equivalent and 2 – 4 years of relevant work experience.
– Master’s degree or international equivalent and 1 – 3 years of relevant work experience.
– Working knowledge of clinical research and the drug development process.
– Strong programming skills.
– Good written and oral communication skills.
– Excellent attention to detail.
– Ability to solve simple to moderate problems.
– Good ability to work in cross-functional teams.
– Good ability to effectively manage multiple tasks and projects.
– Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
– Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
– Exercises judgment within defined procedures and practices to determine appropriate action.
– Builds productive internal/external working relationships.
– Receives minimal guidance on day-today work and moderate guidance on new projects or assignments.

– Develops a programming plan for statistical outputs (datasets, tables, figures, and listings), supporting clinical study reports, regulatory submissions, and publications.
– Gathers requirements and implements data models according to specifications and project timelines (Study Data Tabulation Model (SDTM)/Analysis Dataset Model (ADaM)).
– Develops CDISC (Clinical Data Interchange Standards Consortium) compliant datasets according to dataset specifications and client requirements.
– Develops statistical outputs (tables, listings, and figures) in accordance with Statistical Analysis Plan, Mock shells, and client requirements.
– Ensures all programs and datasets are compliant with CDISC, client standards, SOPs, regulatory requirements, and project-specific guidelines as applicable.
– Read and understand study documents (Protocol, eCRF, dataset specifications, SAP, Mock shells, etc.) as applicable.
– Develops and maintains the SAS programs/macros, creates templates and utilities for data cleaning and reporting, and performs reconciliation of the external data.
– Performs the role of primary and/or validation programmer for all assigned studies.
– Supports and assists with audit-specific requirements for internal/external audits.
– Creates Define.xml, SDRG and ADRG documents.
– Develops SDTM and ADaM specifications compliant to CDISC standards and according to client requirements.
– Develops and validates CDISC compliant datasets (SDTM/ADaM) using dataset specifications.
– Develops SAS programs/macros, templates and utilities for data cleaning and reporting.
– Develops user specific edit check programs to ensure quality of datasets.
– Annotates case report forms (CRF) using dataset specifications and create annotated CRF.
– Reviews CRF annotations and ensures CRF is consistent and meets guidelines of protocol.
– Develops tables, listings and graphs using mock shells.
– Creates annotated mock shells.
– Performs quality control on reports under the guidance of other programmers.
– Supports study documentation in accordance with SOPs by ensuring traceability and regulatory compliance.
– Supports audit specific requirements for internal and external audits.
– Identifies and documents data issues through appropriate trackers.
– Develops and performs quality control on programs, datasets, tables, figures, listings, and any other adhoc reports as required.
– May train and mentor new or junior programmers.

The company offers:
– Benefit package.
– Opportunity to collaborate with a dynamic, forward-thinking team.
– Continuous learning opportunities to remain at the forefront of industry trends & advancement.


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