Senior Statistician

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

📋 Description

• Manage statistical project support independently while offering expert statistical consultancy.

• Oversee statistics support for one or more clinical trial projects or sponsor programs.

• Evaluate study designs, analysis plans, and reports.

• Assist sponsors with the design of clinical trials, including protocol statistical sections, randomization techniques, and statistical analysis plans.

• Consult with internal departments, sponsors, and third-party entities regarding statistical issues and reporting needs.

• Specify and review shells for tables, figures, and listings.

• Create and review specifications for derived datasets and format reports and tabulations.

• Prepare comprehensive final reports that include tables, listings, figures, and writing.

• Develop, assess, execute, and validate SAS programs for the analysis and reporting of clinical study data.

• Maintain documentation for programs as well as validation and testing records.

• Generate ad hoc data summaries and extract trial information from various systems.

• Validate software and test SAS macros in the capacity of system owner or tester.

• Contribute statistical content to manuscripts intended for publication and presentations.

• Support the bidding process through budget evaluations, proposals, and bid defense meetings.

• Drive improvements in systems and processes for the processing and reporting of clinical study data.

• Aid in the development of statistical design and analysis policies.

• Stay informed about statistical methodologies, software packages, and regulatory guidance.

• Assist with Quality Assurance and compliance with audit requirements.

• Support the Director of Biostatistics with additional tasks as necessary.

• Conduct activities in accordance with company, sponsor, ICH, FDA, and 21 CFR Part 11 quality standards.

⛳️ Requirements

• Master's degree in mathematics, statistics, or a related field with a strong statistical focus.

• At least 3 years of statistical experience leading clinical trial projects and conducting data analysis.

• Expert-level project statistician with a proven track record of providing statistical leadership on projects.

• Proficient in design and analysis consultancy across a wide range of applications.

• Computer literate and numerate, with the ability to adapt to various computing systems.

• Familiarity with SAS and nQuery.

• Experience with derived datasets and knowledge of CDISC SDTM and ADaM datasets.

• Understanding of ICH, FDA, and CPMP regulatory guidelines.

• Ability to comply with 21 CFR Part 11 and FDA Quality System Regulations.

• Capable of providing statistical leadership, consultancy, and project support.

• Strong communication skills with the ability to influence, build solid relationships, deliver on commitments, focus on customer needs, and embrace innovation and change.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and collaborative teams.

• Accessible, hands-on leadership.

• Equal employment opportunities for all.

• A professional opportunity to contribute to clinical trials that improve patient lives.