Senior Statistical Programming Consultant

Functional Goal:

Serve as the Sponsor's accountable Statistical Programming representative, ensuring that all statistical programming activities are conducted in compliance with ICH, GCP, regulatory requirements, and company standards, whether performed internally or outsourced to external partners. Provide strategic insight and operational statistical programming expertise across the entire clinical development lifecycle, from study start-up through regulatory submission, approval, and post-submission support.

Support the development, implementation, maintenance, and continuous improvement of statistical programming processes, standards, key performance indicators (KPIs), and innovative technologies, including automation solutions that enhance quality, efficiency, and compliance. Contribute to the governance, maintenance, and optimization of clinical data repositories and analysis platform(s), and data exchange tools to support reliable, traceable, and efficient clinical data management and analysis across development programs.

Main TAsks:

• Ensure completeness, correctness and consistency of clinical programming deliverables in all assigned clinical studies/programs to achieve high quality results in agreement with defined specifications and timelines
• Propose standardization and automation of programming related tasks in collaboration with Biostatistics, Data Management and other clinical functions to improve consistency and efficiency of information management across biosimilars programs.
• Maintain up to date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC). Track emerging trends and apply them to improve programming support across all biosimilars programs.
• Review CRFs/eCRFs and data management specifications documents; Statistical Analysis Plans/mock TLFs.
• Lead data package preparation for electronic submissions. Review of CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewers guides, SAS programs,etc.)
• Subject Matter Expert back up for audits and inspections
• Participate in the set-up of CRO partnerships and provide oversight of outsourced activities
• Collaborate effectively with cross-functional teams and external partners.
• Develop, review, update, and add relevant functional SOPs as company/situations evolve when applicable.
• Support to the management of functional tools for data storage, exchange and analysis

Other Tasks:

• Regular reports on status of programming deliverables quality/progress. Provide input for high level forecasting of timelines and resources for programming tasks.
• Interact proactively and in a solution orientated manner with other clinical and non-clinical functions
• Maintain a high level of expertise in statistical programming methodologies, regulatory requirements, data standards, and emerging digital technologies relevant to clinical development (e.g. metadata-driven programming, visualization technologies, cloud-based analytics platforms, artificial intelligence (AI), etc.). Support the adoption of appropriate technologies, and promote modern, scalable, and inspection-ready solutions that improve data quality, operational efficiency, regulatory compliance, and overall organizational capabilities.

Qualification Profile:

• BSc or Masters degree in computer science, IT, statistics, mathematics or related fields.
• 8+ years of related industry experience within the functional area.
• Thorough understanding of CDISC requirements, data standards principles and data formats accepted by different Health Authorities.
• Advanced SAS experience and proven skills in the use of SAS within a statistical programming environment. Knowledge of other programming languages (e.g. R) would be a plus.
• Excellent understanding of web based Electronic Data Capture and data management systems.
• Strong experience with CRO oversight
• Good knowledge of GxP environment, ICH and other relevant guidance documents (from FDA, EMA,etc.). Knowledge of computerized systems validation processes would be a plus.
• Demonstrates a high degree of autonomy and accountability, with the ability to independently lead and manage statistical programming activities across multiple clinical development program, taking ownership for the quality, timelines, and compliance of assigned deliverables.