Senior Statistical Programmer – FSP

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

📋 Description

• Develop SAS programs to create derived analysis datasets and generate content for tables, listings, and figures; Conduct programming validation to ensure the quality of analysis datasets and programming outputs.

• Offer programming support for project teams, which includes the formulation of programming strategies, standards, specifications, and programmed analyses.

• Assist in the preparation and review of electronic submissions.

• Evaluate key planning documents (such as the statistical analysis plan, data presentation plan, and data review plan) to ensure they align with the objectives of the development team and that programming assumptions and requirements are clear and comprehensive; Assess the impact on programming activities.

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

• Provide leadership in ensuring 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 in interactions with strategic vendors.

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

• Support initiatives for improvement.

⛳️ Requirements

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

• Proficiency in SAS is essential.

• A minimum of 5 years of clinical/statistical programming experience in pharmaceutical clinical development is required.

• Proven proficiency in analytical programming.

• In-depth understanding of clinical data structures (such as CDISC standards) and relational databases.

• Demonstrated skills in using software tools and applications, including MS Office, XML, and Pinnacle 21.

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

• Proven ability to deliver outputs that meet downstream requirements, such as ADaM, Data Definition Table, and e-submission.

• A solid understanding of regulatory, industry, and technology standards and requirements.

• Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs is essential.

• Proven ability to work collaboratively in a team environment with clinical team members.

🏝️ Benefits

• Competitive financial packages.

• Opportunities for training and development.

• Fully flexible work arrangements.

• A healthy work/life balance.