Senior Statistician

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Oversee statistical project support autonomously while offering expert consultancy in statistics.

• Manage statistical assistance for projects or sponsor-led programs.

• Evaluate study designs, analysis plans, and associated reports.

• Aid sponsors in designing clinical trials, developing protocols, randomization methods, and statistical analysis plans.

• Collaborate with internal teams, sponsors, and external partners regarding statistical challenges and reporting needs.

• Define and assess tables, figures, and listing shells.

• Draft and review specifications for derived datasets.

• Compile final reports, inclusive of tables, listings, figures, and written content.

• Create, assess, execute, and validate SAS programs for analyzing and reporting clinical study data.

• Maintain documentation for program descriptions, validation, and other necessary records.

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

• Validate software and conduct testing for SAS macros.

• Contribute statistical insights for manuscripts intended for publication and presentations.

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

• Spearhead enhancements in systems and processes for clinical study data processing and reporting.

• Support the development of policies for statistical design and analysis.

• Aid in fulfilling quality assurance and audit obligations.

• Assist the Director of Biostatistics with various responsibilities related to the role.

• Conduct activities in alignment with company standards, sponsor expectations, ICH, FDA guidelines, and 21 CFR Part 11 regulations.

• Undertake additional tasks as assigned.

⛳️ Requirements

• Proficient with computers and numerate, with the capability to adapt to diverse computer systems.

• Experienced project statistician with expert-level skills in providing statistical leadership for projects.

• Possess consultancy skills in design and analysis across a wide array of applications.

• Customer-oriented, committed to fulfilling obligations, fostering strong relationships, and effectively communicating while embracing innovation and change.

• Master’s degree in mathematics, statistics, or a closely related field with a strong statistical emphasis.

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

• Familiarity with statistical software such as SAS and nQuery.

• Understanding of regulatory guidance documents, including ICH, FDA, and CPMP standards.

• Ability to adhere to relevant quality standards, including FDA Quality System Regulation and 21 CFR Part 11.

🏝️ Benefits

• A diverse and inclusive work environment.

• Supportive and cohesive team dynamics.

• Accessible leadership opportunities.

• Equal employment opportunities for all.

• Exceptional experiences for employees.