SUMMARY

• Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines.

WORK EXPERIENCE:

• Biostatistics.
• Clinical Research Phases.
• R&D Portfolio Management.
• Statistical Programming.
• Data Management & Systems.
• Regulatory Submissions.
• Innovative & Analytical Technologies.
• Clinical Trial Design, Data Review & Reporting.

SKILLS:

• Classification Systems.
• Clinical Trials.
• Computer Data Storage.
• Computer Programming.
• Cross-Functional Teams.
• Data Analysis.
• Data Structures.
• Initiative.
• Programming Languages.
• Reporting.
• Statistical Analysis.
  Job Types: Full-time, Permanent
  Pay: £50,000.00-£60,000.00 per year
  Work Location: Remot

(TLFs) in compliance with CDISC standards and regulatory requirements.

• Serve as the primary point of contact for programming on assigned studies or projects.
• Participate in study-level and project-level planning, timelines, and resource allocation.
• Provide technical guidance and mentorship to junior programmers and contractors.
• Collaborate with Biostatisticians and other stakeholders to define specifications and resolv

• Lead programming activities for clinical study submissions, ensuring timely and high-quality

deliverables.

• Develop, review, and maintain SDTM and ADaM datasets, Tables, Listings, and Figures

(TLFs) in compliance with CDISC standards and regulatory requirements.

• Serve as the primary point of contact for programming on assigned studies or projects.
• Participate in study-level and project-level planning, timelines, and resource allocation.
• Provide technical guidance and mentorship to junior programmers and contractors.
• Collaborate with Biostatisticians and other stakeholders to define specifications and resolve

data-related issues.

• Ensure compliance with Good Clinical Practices (GCP), SOPs, and relevant regulatory

guidelines (e.g., FDA, EMA).