Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
Tailor your resume to this Senior Statistician - UK/Europe - Remote role.
Rezi rewrites your resume against Worldwide Clinical Trials's job description. Free.
Tailor your resume to this Senior Statistician - UK/Europe - Remote role.
Rezi rewrites your resume against Worldwide Clinical Trials's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Senior Statistician - UK/Europe - Remote posting at Worldwide Clinical Trials — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Senior Statistician - UK/Europe - Remote posting at Worldwide Clinical Trials — free, in seconds.
About the Role
Independently manage statistical project support and provide expert statistical consultancy across the stats function.
Responsibilities
- Manage statistics support to one or more projects/sponsor programs, ensuring needs are met by expert and timely statistical consultancy.
- Provide expert review of study designs, analysis plans, and reports.
- Assist sponsors in the design of clinical trials, including statistical sections of study protocols, randomization methodology, and writing statistical analysis plans.
- Consult with internal departments, sponsors, and third parties regarding statistical issues and reporting requirements.
- Provide project support to the statistics reporting process through specification/review of tables, figures, and listings shells, writing/review of derived dataset specifications, and formatting of report documents and tabulations.
- Prepare final reports, including the production of tables, listings, and figures, and report writing.
- Develop, evaluate, and run SAS programs for statistical analysis and reporting of clinical study data, including programs for derived datasets, CDISC, SDTM, ADaM datasets, tables, figures, listings, and their validation.
- Ensure the maintenance of documentation, e.g., the description of programs and validation.
- Produce ad hoc data summaries when requested during a trial.
- Extract information from the system during a trial, e.g., summaries, data listings, study data sets.
- Validate software, in the role of system owner or tester, and test SAS Macros, maintaining required validation and testing documentation.
- Make statistical contributions to manuscripts for publication/presentation.
- Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings.
- Lead the identification of system and process improvements, and develop and implement solutions to improve efficiency and quality of clinical study data processing and reporting.
- Support the development of statistical design and analysis policies.
- Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents (e.g., ICH, FDA, and CPMP points to consider).
- Assist with Quality Assurance and Audit requirements.
- Assist the Director of Biostatistics with all other aspects of the job as required.
- Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant ICH standards, and specifically with FDA Quality System Regulation (including 21CFR Part 11).
- Perform other duties as assigned.
Requirements
- Computer literate and numerate with a proven ability to adapt to various computer systems.
- Expert-level project statistician experienced in providing statistical leadership to projects.
- Design and analysis consultancy skills and knowledge across a broad range of applications.
- Key competencies in customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change.
Skills
- SAS
- nQuery
- CDISC
- SDTM
- ADaM
Experience Level
- Minimum 3 years of statistical experience leading clinical trial projects and data analysis
Education Level
- Master's level in mathematics, statistics, or another subject required with a strong statistical component
About the Company
- Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates and invents.
- Our mission is to work with passion and purpose every day to improve lives.
- We believe everyone plays an important role in making a world of difference for patients and their caregivers.
- We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
- We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
Equal Opportunity
- Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
- We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.
- We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.
- We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.