Senior/Principal Biostatistician - Remote

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development., Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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Ihre Aufgaben

Lead methodological and statistical aspects of one or several clinical studies, with minimum supervision of statistical project leader and/or team leader, Provide support and leadership to the clinical trial study and/or project team on all relevant statistical matters:

• Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses,

• Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables)…,

• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan,

• Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties,

• Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.

• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.

• Review submission documents, such as IND, NDA, BLA, CTE or cTD to ensure statistical validity and accuracy

• Contribute to define and review the specific deliverables related to Transparency and Disclosure

• Provide technical guidance to junior staff.

• Plan and track study/project activities and timelines.

• Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.

Ihr Profil

A Senior Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.,

• PhD/MS in statistics or related discipline with at least 4 years of pharmaceutical experience

• Good knowledge of pharmaceutical clinical development, together with Late Phase and/or early Phase experience.

• Broad knowledge and good understanding of advanced statistical concepts and techniques

• Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (R, …)

• Ability to work in team environment

• Good written and oral communication skills in an English global environment