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  • Posted: Mar 1, 2022
    Deadline: Not specified
  • Cytel Inc., an advanced analytics leader with over thirty years of experience providing sophisticated quantitative insights to executive decision-makers in the lifesciences. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably...
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    Consultant, Innovative Designs

    We are hiring a Consultant to join our Strategic Consulting Practice. As a seasoned Biostatistician, you will leverage and broaden Cytel’s reputation for thought leadership and innovative services by leading engagements for pharmaceutical, biotech and device clients, and building and maintaining successful long-term relationships with clients in collaboration with Cytel’s business developers and other personnel related to the account.  This includes developing and demonstrating thought leadership in statistical methodology for clinical development, ensuring that Cytel remains at the leading edge, and raising Cytel brand awareness and recognition throughout the industry. 

    Specifically, we are looking for leaders with a strong foundation in statistics plus broad expertise and/or unique knowledge in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory, clinical and/or market access pathways and promote faster patient access to better health technologies.

    Specific duties and responsibilities:

    • Accountable for executing of assigned projects on time and with expected quality.  Participate directly in development of the deliverables or completion of other project activities.
    • As required, manage project team to ensure specified deliverables are developed and undergo appropriate review and sign off.
    • Keep abreast with regulatory, reimbursement and other industry requirements and guidelines, including via active participation in scientific conferences and symposia.
    • The position requires regular travel, substantial direct contact with senior management and executives at prospects and existing clients, and the ability to build and leverage strong interpersonal business relationships both internally and externally to Cytel.

    Qualifications and Experience:

    • Strong understanding of the biopharmaceutical R&D process in combination with solid business acumen and an appreciation of the broader business issues.
    • Experience in translating complex methods and approaches internally and in client environments. Strong technical-writing, oral communication and presentation skills, excellent use of the English language.
    • Strong problem-solving and analytical skills, and the ability to execute in client situations at the tactical level.  For analytical roles, knowledge of relevant analytical packages is required (SAS, STATA, R, Python, C/C++).
    • Comfortable presenting and interfacing with senior executives within the clients.
    • Collaborative, entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment.
    • Minimum of a Masters (PhD desirable) in Mathematics, Biostatistics, or a related field; MBA, MD, or advanced degree highly desirable; at least 5-10 years of experience in the consulting, clinical trials or health research environment.

    go to method of application »

    Senior Biostatistician

    The Senior Biostatistician provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Responsibilities include: providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data); communicating with clients regarding study protocol or statistical analysis issues; and writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.

    The Senior Biostatistician analyzes clinical trial data producing accurate results representing the outcome of the trial, validates statistical output, accurately interprets and clearly communicates statistical results and concepts to non-statisticians. With the medical writer, co-authors final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report. The Senior Biostatistician also provides statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

    The Senior Biostatistician provides input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participates in interactions with regulatory agencies, as required. In addition, the Senior Biostatistician collaborates effectively with members of clinical trial implementation teams and with Biometrics colleagues, and keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

    Qualifications and Experience:

    • Master's degree in Statistics or Biostatistics
    • 5-8 years statistical analysis related to clinical trials or health research environment
    • Excellent written and oral communication skills, including grammatical/technical writing skills
    • Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
    • SAS and R proficiency 

    Method of Application

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