Principal Biostatistician (Early Development)
Principal Biostatistician (Early Development)

Principal Biostatistician (Early Development)

Vollzeit 54000 - 84000 € / Jahr (geschätzt) Kein Home Office möglich
Cytel Software Corporation

Auf einen Blick

  • Aufgaben: Lead statistical aspects of clinical studies and collaborate with cross-functional teams.
  • Arbeitgeber: Cytel is a leader in biostatistics and operations research for life sciences.
  • Mitarbeitervorteile: Enjoy significant professional growth and a collaborative work environment.
  • Warum dieser Job: Make impactful contributions to clinical development and regulatory submissions.
  • Gewünschte Qualifikationen: Master's or Ph.D. in Statistics with relevant industry experience required.
  • Andere Informationen: Expect 3 hours overlap with East Coast team; TA experience in Immunology, Cardiovascular, or Neurology preferred.

Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € 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, 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.

As a Technical Lead, Biostatistics independently leads the development and execution of statistical aspects for studies of low to moderate complexity, participates in PRC (Protocol Review Committee) reviews of study protocols and SAPs, and provides data interpretation for study documents like CSR. This role also includes participation in statistical organization continuous improvement initiatives.

Summary of Job Responsibilities:

  • Member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
  • Have responsibilities for integrated summaries and/or supporting a particular indication of an asset.
  • Develop collaborative relationships and work effectively with the GBS (Global Biometric Sciences) Biostatistics Lead, the GBS Planning and Execution Lead, the medical monitor, the protocol manager, the data manager, the PK scientist, and other members of the study/indication team.
  • Responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level.
  • Has responsibility for driving the selection of optimal study designs, data collection, analytic approaches, and rigorous interpretation of trial data.
  • This person may interact with external vendors, key opinion leaders, and regulatory agencies.

Qualifications and Experience:

  • Master's degree in Statistics or equivalent & 5 years of industry-related experience OR Ph.D. in Statistics or equivalent & 3 years of industry-related experience.
  • Demonstrated knowledge of statistical/clinical trials methodology as it relates to clinical development.
  • Relevant prior data analysis planning, execution, and delivery experience.
  • Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
  • Excellent verbal and written communication skills.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Ability to organize multiple work assignments and establish priorities.
  • Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

TA experience preferred: Immunology, Cardiovascular, or Neurology. Phase experience in 1 or 2. Experience with food effect, dose escalations, special populations, SAD/MAD designs, preferred. Expectation of 3 hours overlap with East Coast team.

Principal Biostatistician (Early Development) Arbeitgeber: Cytel Software Corporation

Cytel Software Corporation is an exceptional employer that fosters a collaborative and innovative work environment, particularly for the role of Principal Biostatistician in Early Development. With a strong emphasis on professional growth, employees are encouraged to develop their skills while contributing to impactful clinical research projects. Located in India, Cytel offers unique advantages such as flexible working arrangements, a diverse team, and the opportunity to engage with global regulatory bodies, making it an ideal place for those seeking meaningful and rewarding careers in the life sciences.
Cytel Software Corporation

Kontaktperson:

Cytel Software Corporation HR Team

StudySmarter Bewerbungstipps 🤫

So bekommst du den Job: Principal Biostatistician (Early Development)

Tip Number 1

Make sure to familiarize yourself with the latest trends and methodologies in biostatistics, especially those relevant to clinical trials. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in the field.

Tip Number 2

Network with professionals in the biostatistics and clinical development fields. Attend industry conferences or webinars where you can meet potential colleagues and learn more about Cytel's work culture and projects.

Tip Number 3

Prepare to discuss specific examples from your past experience that showcase your ability to lead statistical aspects of studies. Highlight any collaborative projects you've been involved in, especially those that required cross-functional teamwork.

Tip Number 4

Understand Cytel's focus areas, particularly in Immunology, Cardiovascular, or Neurology. Tailor your discussions to reflect how your background aligns with their needs and how you can contribute to their ongoing projects.

Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Principal Biostatistician (Early Development)

Statistical Analysis
Clinical Trial Methodology
Data Interpretation
Cross-Functional Team Collaboration
Regulatory Submission Preparation
Study Design Optimization
Analytic Approach Development
Excellent Verbal and Written Communication
Project Management
Interpersonal Skills
Adaptability to Change
Prioritization and Organization
Experience in Immunology, Cardiovascular, or Neurology
Knowledge of SAD/MAD Designs
Data Analysis Planning and Execution

Tipps für deine Bewerbung 🫡

Understand the Role: Make sure to thoroughly read the job description for the Principal Biostatistician position. Understand the key responsibilities and qualifications required, such as experience in statistical methodology and clinical trials.

Tailor Your CV: Customize your CV to highlight relevant experience in biostatistics, particularly in early development and clinical trials. Emphasize your educational background, especially if you have a Master's or Ph.D. in Statistics.

Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for biostatistics and your ability to work within cross-functional teams. Mention specific experiences that align with the responsibilities listed in the job description.

Highlight Communication Skills: Since excellent verbal and written communication skills are crucial for this role, provide examples in your application that demonstrate your ability to communicate complex statistical concepts effectively.

Wie du dich auf ein Vorstellungsgespräch bei Cytel Software Corporation vorbereitest

Showcase Your Statistical Expertise

Be prepared to discuss your knowledge of statistical methodologies and how they apply to clinical trials. Highlight specific examples from your past experience where you successfully led statistical aspects of studies.

Demonstrate Cross-Functional Collaboration

Cytel values teamwork, so be ready to share instances where you've worked effectively with cross-functional teams. Discuss how you contributed to trial design and protocol development, emphasizing your role in fostering collaboration.

Prepare for Regulatory Discussions

Since the role involves interactions with regulatory agencies, familiarize yourself with the regulatory submission process. Be ready to explain how your contributions have supported successful global regulatory filings in previous roles.

Communicate Clearly and Effectively

Excellent communication skills are crucial for this position. Practice articulating complex statistical concepts in a clear and concise manner. Prepare to discuss how you adapt your communication style to different audiences within the organization.

Principal Biostatistician (Early Development)
Cytel Software Corporation Jetzt bewerben
Cytel Software Corporation
  • Principal Biostatistician (Early Development)

    Vollzeit
    54000 - 84000 € / Jahr (geschätzt)
    Jetzt bewerben

    Bewerbungsfrist: 2026-10-31

  • Cytel Software Corporation

    Cytel Software Corporation

    500 - 1000
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