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Senior Statistician

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🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

đźź  Senior

đź‘» Ghost score 25%

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Lifelancer

51 - 200 employees

Founded 2020

đź’Ľ Consulting

🏥 Healthcare

📦 Logistics

đź’° Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

đź“‹ Description

• Independently manage statistical project support and provide expert statistical consultancy • Manage statistics support for one or more clinical trial projects or sponsor programs • Review study designs, analysis plans, and reports • Assist sponsors with clinical trial design, protocol statistical sections, randomization methodology, and statistical analysis plans • Consult with internal departments, sponsors, and third parties on statistical issues and reporting requirements • Specify and review tables, figures, and listings shells • Write and review derived dataset specifications and format reports and tabulations • Prepare final reports, including tables, listings, figures, and report writing • Develop, evaluate, run, and validate SAS programs for clinical study data analysis and reporting • Maintain program documentation and validation/testing documentation • Produce ad hoc data summaries and extract trial information from systems • Validate software and test SAS macros as system owner or tester • Contribute statistical content to manuscripts for publication and presentation • Support bidding through budget reviews, proposals, and bid defense meetings • Lead system and process improvements for clinical study data processing and reporting • Support development of statistical design and analysis policies • Maintain knowledge of statistical methodologies, software packages, and regulatory guidance • Assist with Quality Assurance and audit requirements • Assist the Director of Biostatistics with other job aspects as required • Perform activities in compliance with company, sponsor, ICH, FDA, and 21 CFR Part 11 quality standards

🎯 Requirements

• Master's level in mathematics, statistics, or another subject with a strong statistical component • Minimum 3 years of statistical experience leading clinical trial projects and data analysis • Expert-level project statistician experienced in providing statistical leadership to projects • Design and analysis consultancy skills across a broad range of applications • Computer literate and numerate, with ability to adapt to various computer systems • Knowledge of SAS and nQuery • Experience with derived datasets and CDISC SDTM and ADaM datasets • Knowledge of ICH, FDA, and CPMP regulatory guidance • Ability to comply with 21 CFR Part 11 and FDA Quality System Regulation • Ability to provide statistical leadership, consultancy, and project support • Ability to communicate, influence, build strong relationships, deliver on commitments, focus on customers, and embrace innovation and change

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible, hands-on leadership • Equal employment opportunities • Professional opportunity to work on clinical trials improving patient lives

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