At a Glance
- Tasks: Lead late phase Oncology clinical studies and provide statistical expertise.
- Company: Cytel is a pioneering company in clinical development, dedicated to innovation in patient treatment.
- Benefits: Enjoy autonomy, ownership, and the support of a collaborative team.
- Why this job: Be part of groundbreaking research that impacts patient care and drives clinical development forward.
- Qualifications: Ph.D. or MS in Statistics/Biostatistics with 6+ years in clinical development required.
- Other info: Fluency in English is essential; knowledge of SAS and CDISC preferred.
The predicted salary is between 42000 - 66000 Β£ per year.
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Who Are You?
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead
Job Description
Who Are You?
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead late phase Oncology clinical studies across your region. You are excited and enthusiastic, 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 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 Principal Biostatisticians provide statistical and development support and influence for the associated client\’s trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
Responsibilities
As a Principal Biostatistician, your responsibilities will include:
- Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
- Needs to be experienced in Oncology (preferred in hematology and late phase) and expected to have prior experience of working on a registrational study, playing an independent statistician role, sitting in study team meetings and discussing with the team on statistical analysis plan, design of outputs, addressing health authority questions
- Lead statistical teams on clinical development projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
- Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
- Needs familiarity with ADAM and SDTM and can do hands-on work (e.g., derive outputs or summary statistics) to address teamβs questions quickly
- When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
- Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
- Contribute to the development of sourcing strategy for projects.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
Qualifications
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
Qualifications And Experience
- Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
- Minimum Work Requirements:
- At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development.
- At least 3 years of experience as a Lead Biostatistician for clinical development projects.
- Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data e-submission to FDA.
- Fluent in English (French or German is a plus).
- Working SAS & CDISC knowledge.
- Experience in R is a plus.
Skills
- Works effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups.
- Understands and anticipates customer needs and responds to their inquiries.
- Verbal and written communication is effective with multi-disciplinary groups.
- Work is well-organized, of high-quality, meeting timelines. Able to balance concurrent tasks and responsibilities.
- Excellent time management.
- Brings creative ideas and makes suggestions for optimization.
- Exhibits leadership for the biostatistics team working on the same clinical development teams.
- Exhibits the ability to mentor and develop statistical colleagues.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research, Analyst, and Information Technology
-
Industries
Pharmaceutical Manufacturing
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Principal Biostatistician FSP - Late Phase Oncology employer: Cytel
Contact Detail:
Cytel Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Principal Biostatistician FSP - Late Phase Oncology
β¨Tip Number 1
Network with professionals in the biostatistics and oncology fields. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends. This can help you gain insights into what Cytel values in candidates.
β¨Tip Number 2
Familiarise yourself with Cytel's recent projects and publications in late-phase oncology. Understanding their work will allow you to speak knowledgeably during interviews and demonstrate your genuine interest in their mission.
β¨Tip Number 3
Prepare to discuss your experience with regulatory submissions and interactions, as this is a key aspect of the role. Be ready to share specific examples of how you've successfully navigated these processes in past projects.
β¨Tip Number 4
Showcase your leadership skills by preparing examples of how you've mentored junior statisticians or led teams in previous roles. Highlighting your ability to motivate and guide others will align well with the expectations for this position.
We think you need these skills to ace Principal Biostatistician FSP - Late Phase Oncology
Some tips for your application π«‘
Tailor Your CV: Make sure your CV highlights relevant experience in biostatistics, particularly in oncology and clinical development. Emphasise your leadership roles and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical development and your ability to lead statistical teams. Mention specific experiences where you have successfully collaborated with cross-functional teams or contributed to regulatory submissions.
Highlight Technical Skills: Clearly list your technical skills, especially in SAS, CDISC, and any experience with R. Provide examples of how you've applied these skills in previous roles, particularly in late-phase oncology studies.
Showcase Leadership and Communication: Demonstrate your leadership abilities and effective communication skills in your application. Include examples of mentoring colleagues or leading teams, as well as how you have effectively communicated complex statistical concepts to non-statistical stakeholders.
How to prepare for a job interview at Cytel
β¨Showcase Your Statistical Expertise
As a Principal Biostatistician, it's crucial to demonstrate your deep understanding of statistical methods and their application in clinical development. Be prepared to discuss specific methodologies you've used in past projects, especially in oncology, and how they contributed to successful outcomes.
β¨Highlight Leadership Experience
Since the role involves leading statistical teams, share examples of how you've successfully managed teams in previous roles. Discuss your approach to motivating team members and ensuring alignment with project objectives, as this will show your capability to lead effectively.
β¨Prepare for Regulatory Discussions
Given the importance of regulatory interactions in this position, brush up on relevant international guidelines and be ready to discuss your experience with regulatory submissions. Highlight any direct interactions you've had with regulatory authorities and how you navigated those discussions.
β¨Demonstrate Collaboration Skills
This role requires strong collaboration with cross-functional teams. Prepare to provide examples of how you've worked effectively within multidisciplinary groups, addressing customer needs and responding to inquiries. This will showcase your ability to thrive in a matrix organisation.