Senior 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 Senior Statistical Programmer, who will provide statistical programming support and expertise for the implementation of data models and the reporting of clinical trials.
Requirements:
– Bachelor’s degree or master’s degree or international equivalent in statistics, computer science or life sciences.
– Bachelor’s degree or international equivalent and 3–7 years of relevant work experience.
– Master’s degree or international equivalent and 2–6 years of relevant work experience.
– In-depth knowledge of clinical research and the drug development process.
– Strong programming skills.
– Strong written and oral communication skills.
– Excellent attention to detail.
– Ability to solve moderate to complex problems.
– Strong ability to effectively manage multiple tasks and projects.
– Ability to lead and coordinate small teams.
– A seasoned professional with full understanding of area of specialization.
– Resolves a wide range of issues in creative ways.
– Fully qualified level of the role.
– Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
– Exercises judgment in selecting methods and techniques for obtaining solutions.
– Networks with senior internal and external personnel in area of expertise.
– Works independently and receives minimal guidance on day-today work and new projects or assignments.
Responsibilities:
– 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 programming plan for statistical outputs, supporting clinical study reports, regulatory submissions, and publications.
– Develops and maintains SAS programs/macros, templates and utilities for data cleaning and reporting. Reconciles external data.
– Annotates case report forms (CRF) using dataset specifications and create annotated CRF.
– Performs quality control on internally created statistical outputs to achieve first time right (FTR) outputs.
– Initiates protocol and SAP discussion.
– Develops and performs quality control on programs, datasets, tables, figures, listings, and any other adhoc reports as required.
– Provides advanced technical expertise to programming team.
– Trains and mentors new or junior programmers.
– May manage resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
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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