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- Aufgaben: Lead and support Phase I-IV clinical studies with advanced statistical methods.
- Arbeitgeber: Cytel is a global CRO focused on innovative biostatistical software and services.
- Mitarbeitervorteile: Enjoy competitive rewards, world-class benefits, and supportive policies for your career growth.
- Warum dieser Job: Join a passionate team driving the next generation of patient treatment and clinical development.
- Gewünschte Qualifikationen: Master's degree in statistics; Ph.D. preferred; 5+ years in clinical trials required.
- Andere Informationen: Work embedded within a global pharmaceutical client, fostering autonomy and ownership.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
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.
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.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues. Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities.
Your responsibilities will include:
- Providing statistical support to clinical studies
- Participating in the development of study protocols, including participation in study design discussions and sample size calculations
- Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
- Performing statistical analyses and interpreting statistical results
- Preparing clinical study reports, including integrated summaries for submissions
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
To be successful in this position you will have:
- Master's degree in statistics or a related discipline. Ph.D. strongly desired.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
- Experience working for a CRO is strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
- Knowledge of R programming is a plus.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
Why Cytel?
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.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Sanofi Vx - Senior Biostatistician Arbeitgeber: Cytel Software Corporation
Kontaktperson:
Cytel Software Corporation HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Sanofi Vx - Senior Biostatistician
✨Tip Number 1
Familiarize yourself with the specific statistical methods and software mentioned in the job description, such as SAS and R. Being able to discuss your experience with these tools during the interview will demonstrate your readiness for the role.
✨Tip Number 2
Highlight any previous experience you have with clinical trials, especially if you've worked on Phase I-IV studies. Be prepared to share specific examples of how you contributed to study design or statistical analysis in those projects.
✨Tip Number 3
Showcase your ability to communicate complex statistical concepts in simple terms. This is crucial for collaborating with clinical and regulatory colleagues, so think of examples where you've successfully explained methodologies to non-statisticians.
✨Tip Number 4
Research Cytel's recent projects and initiatives in the biostatistics field. Being knowledgeable about their work will not only help you tailor your responses but also show your genuine interest in being part of their team.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Sanofi Vx - Senior Biostatistician
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior Biostatistician position. Highlight your experience in clinical trials, statistical analysis, and any relevant software skills in your application.
Tailor Your CV: Customize your CV to reflect your experience in the pharmaceutical or biotechnology industry. Emphasize your expertise in SAS programming, sample size calculations, and your ability to communicate complex methodologies effectively.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical development and your motivation to contribute to Cytel's mission. Mention specific projects or experiences that demonstrate your ability to lead and collaborate with teams.
Highlight Regulatory Experience: If you have experience with regulatory submissions or working with CDISC requirements, make sure to highlight this in your application. This is a valuable asset that can set you apart from other candidates.
Wie du dich auf ein Vorstellungsgespräch bei Cytel Software Corporation vorbereitest
✨Show Your Passion for Clinical Development
Make sure to express your enthusiasm for clinical development during the interview. Share specific examples of how you've contributed to advancing clinical studies in your previous roles, and demonstrate your commitment to pushing the boundaries of what's possible in this field.
✨Highlight Your Statistical Expertise
Be prepared to discuss your experience with advanced statistical methods and how you've applied them in clinical trials. Bring up your familiarity with sample size calculations, protocol development, and statistical analysis plans (SAPs) to showcase your technical skills.
✨Demonstrate Effective Communication Skills
Since the role requires strong communication abilities, practice explaining complex statistical concepts in simple terms. Prepare to discuss how you've successfully communicated methodologies and results to both technical and non-technical stakeholders in the past.
✨Prepare for Regulatory Discussions
Given the importance of regulatory work in this position, familiarize yourself with common regulatory questions and how they translate into statistical problems. Be ready to discuss any relevant experience you have in collaborating with clinical and regulatory teams.
