Senior Statistical Programmer, Georgia, Poland, Serbia, Hungary

This is a fully remote position, open to applicants in Hungary, +3 more countries.

📋 Description

• Develop SAS programs to create derived analysis datasets, tables, listings, and figures.

• Conduct programming validation to guarantee the quality of analysis datasets and programming outputs.

• Offer programming assistance to project teams, which includes developing programming strategies, standards, specifications, and programmed analyses.

• Aid in the preparation and review of electronic submissions.

• Evaluate statistical analysis plans, data presentation plans, and data review plans for consistency, clarity, completeness, and programming implications.

• Collaborate with vendors regarding project standards, programming conventions, specifications, and file transfers.

• Oversee quality assurance of deliverables through adherence to consistent standards and compliance with regulatory requirements, guidelines, SOPs, and best practices.

• Spot opportunities for enhancing efficiency and consistency within the team and vendor interactions.

• Independently manage and/or execute programming tasks with minimal supervision.

• Contribute to improvement initiatives.

• Work collaboratively as part of a dedicated team supporting a single sponsor.

⛳️ Requirements

• A Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences is essential.

• At least 5 years of experience in clinical/statistical programming within pharmaceutical clinical development is required.

• Proficiency in SAS is mandatory.

• Experience with R is considered a strong advantage.

• Comprehensive understanding of clinical data structure, including CDISC standards and relational databases.

• Proven ability to manage and process upstream data, including multiple data forms, workflow, eDC, and SDTM.

• Demonstrated capability to produce outputs that meet downstream requirements, such as ADaM, Data Definition Table, and e-submission.

• Proficient in using MS Office, XML, and Pinnacle 21.

• Solid understanding of regulatory, industry, and technological standards and requirements.

• Familiarity with statistical terminology, clinical tests, medical terminology, and protocol designs is essential.

• Candidates must be authorized to work in Georgia, Poland, Serbia, or Hungary.

• Not able to sponsor or assume sponsorship of an employment visa.

🏝️ Benefits

• Competitive financial packages

• Training and development opportunities

• Smooth onboarding and training program

• Healthy work/life balance

• Fully flexible work arrangement

• Option for fully remote work

• Office desk available for employees residing close to the office who wish to utilize it