Principal Biostatistician - Medical Affairs
Principal Biostatistician - Medical Affairs

Principal Biostatistician - Medical Affairs

Vollzeit 72000 - 108000 € / Jahr (geschätzt) Kein Home Office möglich
Cytel Software Corporation

Auf einen Blick

  • Aufgaben: Lead statistical activities for Medical Affairs, including study design and data analysis.
  • Arbeitgeber: Cytel is a leader in biostatistics and operations research for life sciences.
  • Mitarbeitervorteile: Enjoy career growth opportunities and work with top industry professionals.
  • Warum dieser Job: Shape the future of drug development in a dynamic, entrepreneurial environment.
  • Gewünschte Qualifikationen: PhD or MS in Biostatistics with relevant experience; SAS programming skills required.
  • Andere Informationen: Join a high-growth company with potential for senior leadership roles.

Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, because 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.

In this role you will join our FSP department and will work for our clients, a growing biotech. As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses.

You will contribute by:

  • Collaborating with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.
  • Writing the statistical sections of study protocols, while consulting with internal and external experts.
  • Contributing to or preparing statistical analysis plans.
  • Collaborating with Data Management and Medical Research on design of eCRFs.
  • Providing statistical guidance on conduct of ongoing studies.
  • Being accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs.
  • Contributing observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
  • Contributing to scientific articles, summarizing data collected in studies.
  • Participating in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.
  • Reviewing abstracts, manuscripts for publications and presentations.

What we're looking for:

  • PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years' relevant experience.
  • Excellent written and oral communication and presentation skills.
  • Extensive experience programming in SAS.
  • Extensive experiences working on data analysis with clinical studies database.
  • Experience working on post-approval observational and clinical studies.
  • Understanding of ICH GCP as well as general knowledge of industry practices and standards.
  • Experiences in R programming language and other statistical software.
  • Experience with CDISC, including SDTM, ADaM, CDASH.

What's in it for you:

  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development.
  • You will be part of an exciting new chapter in Cytel's history with high growth and opportunities to progress in Senior and Leadership positions within the company.
  • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation.
  • Work with and leverage the best and brightest minds in the industry.

Principal Biostatistician - Medical Affairs Arbeitgeber: Cytel Software Corporation

Cytel Software Corporation is an exceptional employer that fosters a culture of collaboration and innovation, making it an ideal place for a Principal Biostatistician in Medical Affairs. With a strong commitment to employee growth, Cytel offers significant professional development opportunities and the chance to work alongside industry leaders in a dynamic environment. Located in the US, employees benefit from a supportive atmosphere that encourages entrepreneurial thinking and the implementation of new ideas, all while contributing to the advancement of clinical development.
Cytel Software Corporation

Kontaktperson:

Cytel Software Corporation HR Team

StudySmarter Bewerbungstipps 🤫

So bekommst du den Job: Principal Biostatistician - Medical Affairs

Tip Number 1

Familiarize yourself with the latest trends and methodologies in biostatistics, especially those relevant to Medical Affairs. This knowledge will not only help you during interviews but also demonstrate your commitment to staying current in the field.

Tip Number 2

Network with professionals in the biostatistics and pharmaceutical industries. Attend conferences, webinars, or local meetups to connect with others who may provide insights or referrals for opportunities at Cytel.

Tip Number 3

Prepare to discuss specific projects where you've applied your statistical expertise, particularly in post-approval studies. Be ready to explain your role, the challenges faced, and how you contributed to the success of those projects.

Tip Number 4

Showcase your programming skills in SAS and R during discussions. If possible, bring examples of your work or analyses that highlight your proficiency and how it can benefit the Medical Affairs team at Cytel.

Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Principal Biostatistician - Medical Affairs

PhD in Biostatistics, Statistics, or equivalent
3+ years of pharmaceutical biostatistics experience (or 5+ years with MS)
Excellent written and oral communication skills
Presentation skills
Extensive experience programming in SAS
Data analysis experience with clinical studies databases
Experience with post-approval observational and clinical studies
Understanding of ICH GCP
Knowledge of industry practices and standards
Experience in R programming language
Familiarity with other statistical software
Experience with CDISC standards, including SDTM, ADaM, CDASH

Tipps für deine Bewerbung 🫡

Tailor Your CV: Make sure your CV highlights your relevant experience in biostatistics, particularly in the pharmaceutical industry. Emphasize your programming skills in SAS and R, as well as your experience with clinical studies and post-approval observational studies.

Craft a Strong Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Discuss your experience with statistical analysis plans and your collaboration with medical affairs teams, showcasing how you can contribute to Cytel's goals.

Highlight Communication Skills: Since excellent written and oral communication skills are essential for this role, provide examples in your application of how you've effectively communicated complex statistical concepts to non-statistical audiences or collaborated with cross-functional teams.

Showcase Relevant Projects: Include specific projects or studies you've worked on that relate to the responsibilities of the position. Detail your role in designing studies, writing protocols, or contributing to regulatory documents, as these experiences will strengthen your application.

Wie du dich auf ein Vorstellungsgespräch bei Cytel Software Corporation vorbereitest

Showcase Your Statistical Expertise

Be prepared to discuss your experience with biostatistics in detail. Highlight specific projects where you contributed to study designs or analysis plans, and be ready to explain your role in those projects.

Demonstrate Communication Skills

Since excellent written and oral communication is crucial for this role, practice explaining complex statistical concepts in simple terms. You might be asked to present your findings or collaborate with non-statistical teams, so clarity is key.

Familiarize Yourself with Relevant Software

Make sure you are comfortable discussing your experience with SAS and R programming. Be ready to provide examples of how you've used these tools in past projects, especially in the context of clinical studies.

Understand Industry Standards

Brush up on ICH GCP guidelines and CDISC standards. Being able to discuss these topics will show that you are knowledgeable about industry practices and can contribute effectively to regulatory documents and study reports.

Principal Biostatistician - Medical Affairs
Cytel Software Corporation Jetzt bewerben
Cytel Software Corporation
  • Principal Biostatistician - Medical Affairs

    Vollzeit
    72000 - 108000 € / Jahr (geschätzt)
    Jetzt bewerben

    Bewerbungsfrist: 2026-10-31

  • Cytel Software Corporation

    Cytel Software Corporation

    500 - 1000
  • Weitere offene Stellen bei Cytel Software Corporation

    Cytel Software Corporation
    Senior Biostatistician

    Cytel Software Corporation

    Vollzeit 60000 - 84000 € / Jahr (geschätzt)
    Cytel Software Corporation
    Senior Statistical Programmer

    Cytel Software Corporation

    Rosenheim Vollzeit 48000 - 84000 € / Jahr (geschätzt)
    Cytel Software Corporation
    Principal Biostatistician, DMC

    Cytel Software Corporation

    Vollzeit 72000 - 108000 € / Jahr (geschätzt)
Ähnliche Positionen bei anderen Arbeitgebern
Europas größte Jobbörse für Gen-Z
discover-jobs-cta
Jetzt entdecken
>