Senior Statistical Programmer, Georgia, Poland, Serbia, Hungary

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

📋 Description

• Provide specialized technical knowledge for the execution of clinical trials.

• Serve as an internal subject matter expert in designated areas, offering technical assistance and expert guidance.

• Independently manage programming tasks associated with the analysis and reporting of clinical study data.

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

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

• Offer programming support to project teams, including strategies, standards, specifications, and programmed analysis.

• Assist 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 effects.

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

• Oversee quality assurance for deliverables in accordance with standards, regulatory requirements, guidance, SOPs, and work practices.

• Identify opportunities to enhance efficiency and consistency within the team and in vendor interactions.

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

• Contribute to improvement initiatives.

⛳️ Requirements

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

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

• Proficiency in SAS is essential.

• Experience with R would be a significant advantage.

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

• Proven ability to manage and process upstream data, encompassing 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 software tools and applications, including MS Office, XML, and Pinnacle 21.

• Strong understanding of regulatory, industry, and technology standards and requirements.

• Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.

• Candidates must have authorization to work in Georgia, Poland, Serbia, or Hungary.

• Sponsorship of an employment Visa is not available.

🏝️ Benefits

• Competitive financial packages

• Training and development opportunities

• Comprehensive induction and training program

• Fully flexible work arrangements

• Option for fully remote work

• Support for maintaining a healthy work/life balance

• Employee welfare support