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Senior Biostatistician Consultant- Vaccine & Immunology(Remote in EU)

ClinChoice is a global full-service CRO specializing in clinical development. They are looking for a confident Senior Biostatistician Consultant to work closely with clients and oversee statistical project requirements.

Skills

  • Statistical analysis
  • Statistical oversight
  • Communications skills
  • Mentorship

Responsibilities

  • Responsible for protocol development including study design.
  • Provide statistical oversight to studies.
  • Assure data for statistical analyses are complete and consistent.
  • Manage activities of statisticians across projects.

Education

  • MS or PhD in Statistics or related field.

Benefits

    To read the complete job description, please click on the ‘Apply’ button
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    What You Should Know About Senior Biostatistician Consultant- Vaccine & Immunology(Remote in EU), ClinChoice

    If you're ready to elevate your career, consider joining ClinChoice as a Senior Biostatistician Consultant - Vaccine & Immunology! Here at ClinChoice, we pride ourselves on blending the stability of a global CRO with the unique experience of working directly for a single sponsor. This remote role based in the European Union provides you the perfect opportunity to leverage your skills, particularly in Vaccine and Immunology. As a Senior Biostatistician, you'll be responsible for a variety of interesting tasks—from protocol development and statistical oversight to ensuring data integrity in statistical analyses. You'll get to explore statistical methods and guide your fellow statisticians, all while fostering trustworthy relationships with clients. Our supportive culture emphasizes professional development, so you'll have the resources you need to thrive. ClinChoice is driven by a mission that prioritizes the health of the world by efficiently bringing innovative drugs and devices to market, and you’ll be an integral part of this process. With your expertise in the pharmaceutical or CRO industry, especially with clinical trials and a clear understanding of FDA regulations, you'll help maintain the high standards we pride ourselves on. Ready to make an impact? At ClinChoice, your work matters, and we can't wait for you to join the team!

    Frequently Asked Questions (FAQs) for Senior Biostatistician Consultant- Vaccine & Immunology(Remote in EU) Role at ClinChoice
    What are the main responsibilities of a Senior Biostatistician Consultant at ClinChoice?

    As a Senior Biostatistician Consultant - Vaccine & Immunology at ClinChoice, your primary responsibilities include protocol development, sample size calculations, randomization, and creating statistical analysis plans. You'll also oversee the statistical quality of studies, ensure the data's completeness and accuracy, and guide your peers in statistical methodologies.

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    What qualifications are required for the Senior Biostatistician Consultant position at ClinChoice?

    To qualify for the Senior Biostatistician Consultant role at ClinChoice, candidates should possess a Master’s or PhD in Statistics or Biostatistics, along with relevant experience—3-5 years for PhDs and 6-8 years for MS holders. A strong background in Vaccine and Immunology is essential, as well as experience in clinical trials and regulatory interactions.

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    How does ClinChoice support the professional development of Senior Biostatistician Consultants?

    ClinChoice prioritizes professional growth by providing continuous training, mentorship opportunities, and a collaborative work environment. As a Senior Biostatistician Consultant, you'll not only hone your skills but also have the chance to mentor less experienced statisticians, fostering a culture of learning and excellence.

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    What is the work environment like for a Senior Biostatistician Consultant at ClinChoice?

    The work environment at ClinChoice for a Senior Biostatistician Consultant is dynamic and flexible, as this role is remote within the European Union. You'll benefit from a supportive culture that emphasizes quality and collaboration, allowing for meaningful interactions with clients and peers alike.

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    What makes the Senior Biostatistician Consultant role at ClinChoice unique?

    The Senior Biostatistician Consultant role at ClinChoice stands out for its blend of direct client engagement and the backing of a reputable global CRO. This unique position empowers you to drive statistical analysis while collaborating closely with clients, ensuring high-quality project results.

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    Common Interview Questions for Senior Biostatistician Consultant- Vaccine & Immunology(Remote in EU)
    Can you explain your experience with statistical analysis in clinical trials?

    When answering this question, detail specific experiences you've had with different statistical methodologies, tools you’ve utilized, and how your analyses impacted trial outcomes. Highlight your familiarity with FDA regulations and your role in past successful projects.

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    How do you approach protocol development for a clinical study?

    Discuss your process for protocol development, emphasizing your attention to detail and statistical considerations such as sample size calculation and randomization. Provide examples of previous studies where you developed protocols and the outcomes.

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    Describe a time you had to mentor a less experienced statistician.

    Share a specific situation where you guided a junior statistician, focusing on the skills you taught, how you approached the mentorship, and any positive outcomes or feedback from that experience.

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    What strategies do you use to ensure data quality and integrity?

    Explain your routine for checking data quality, including consistency checks, validation processes, and how you handle discrepancies or flawed data. Providing a real-life example can further demonstrate your approach.

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    How do you keep up with changes in FDA regulations regarding clinical trials?

    Talk about the resources you use to stay informed, such as industry newsletters, professional organizations, or regulatory agency updates. Mention any relevant courses or training that have helped you maintain a current understanding.

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    Can you discuss a challenging statistical problem you've encountered?

    When discussing challenges, provide a clear description of the problem, your analytical approach to solving it, and the final outcome. This illustrates your problem-solving skills and familiarity with statistical methodologies.

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    What software tools are you proficient in for data analysis?

    Mention the statistical software tools you use most frequently, such as SAS, R, or Python, and give examples of projects where you've effectively utilized these tools for analysis and reporting.

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    How do you communicate complex statistical information to non-statistical stakeholders?

    Provide insight into your communication style, emphasizing clarity and simplicity. Discuss specific approaches you use, such as visual aids or analogies, and give an example of how you successfully conveyed information to a non-statistical audience.

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    What is your experience with sample size determination?

    Discuss the methods you typically use for calculating sample sizes for clinical trials, emphasizing how these methods align with study objectives and regulatory guidelines.

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    How do you handle tight deadlines in your work?

    Describe strategies you employ to manage your time effectively under pressure, such as prioritization, delegation, or using project management tools, backed by a real example of meeting a challenging deadline.

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    Our mission is to be a valuable partner to our clients by providing a wide variety of services for product development and regulatory submissions. We continuously strive to raise the standard of excellence through accuracy and efficiency. This re...

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    DATE POSTED
    January 8, 2025

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