Senior Statistical Programmer

This is a fully remote position, open to applicants in Poland.

📋 Description

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

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

• Offer programming assistance to project teams, including the formulation of programming strategies, standards, specifications, and programmed analyses.

• Aid in the preparation and review of electronic submissions.

• Evaluate key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure they align with the objectives of the development team and guarantee the clarity and completeness of programming assumptions and requirements;

• Analyze the impact on programming activities.

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

• Provide leadership to ensure the quality of deliverables by consistently applying standards and adhering to regulatory requirements, guidance, and corporate and departmental SOPs and work practices.

• Identify opportunities to enhance efficiency and consistency within the team and our interactions with strategic vendors.

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

• Support initiatives aimed at improvement.

⛳️ Requirements

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

• Proficiency in SAS is essential.

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

• Proven proficiency in analytical programming.

• Comprehensive understanding of clinical data structures (e.g., CDISC standards) and relational databases.

• Demonstrated skills in utilizing software tools and applications, such as MS Office, XML, and Pinnacle 21.

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

• Proven capability in delivering outputs that meet downstream requirements, such as ADaM, Data Definition Table, and e-submission.

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

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

• Proven ability to collaborate effectively in a team environment with clinical team members.

🏝️ Benefits

• Annual salary review

• Total rewards incentives

• Flexible work arrangement

• Opportunities for professional development