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Principal Biostatistician Fsp - Late Phase Oncology

9+ years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Who Are You?

As an experienced Principal Biostatistician with a passion for clinical development and statistical analysis, you are adept at using advanced statistical methods to lead Phase I-IV clinical studies across your region. You are enthusiastic, driven, and excel in motivating teams to deliver high-quality work while collaborating seamlessly with clients. You are not satisfied with the status quo and are always pushing clinical development to its full potential, inspiring others to do the same.


Sponsor-Dedicated Role:

Working fully embedded within one of our pharmaceutical clients and with the support of Cytel, you will be at the core of our client’s innovation. As a Biostatistician, you will be dedicated to one of our global pharmaceutical clients—an industry leader in the next generation of patient treatments—where individuals are empowered to take ownership and work autonomously. This is an exciting opportunity to be part of a groundbreaking program.


Position Overview:

Our Principal Biostatisticians provide statistical leadership and support for our client's trials. You will offer expertise in processes, clinical development plans, concept sheets, and protocols, and may also oversee work supported by other vendors. Your role will include formulating integrated analytical approaches, utilizing statistical methods, machine learning, and deep learning algorithms to derive actionable insights and automate processes, ultimately reducing time and effort for repeated use.


Responsibilities:

As a Principal Biostatistician, your responsibilities will include:

  • Provide statistical leadership and expertise in clinical development plans, concept sheets, and protocols for Oncology studies, representing Cytel and the statistical team on the client’s Product Development Teams.
  • Lead statistical teams on clinical development projects, ensuring alignment of objectives and timely delivery of statistical outputs that meet project requirements. Coordinate all statistical aspects across clinical trials for each assigned project.
  • Provide statistical input into study protocols, Case Report Forms (CRFs), data management plans, write statistical analysis plans (SAPs), review or create analysis dataset specifications, and perform statistical analyses for late-phase Oncology projects.
  • Review and contribute to study reports and the clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate in meetings with regulatory authorities.
  • When in the Lead Biostatistician role, manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables, and processes.
  • Foster the use of innovative statistical methodologies by identifying, adapting, developing, or utilizing optimal research methodologies and techniques for each project. Contribute internally and externally to the company’s visibility through expertise and customer orientation.
  • Contribute to the development of sourcing strategies for projects.
  • Build strong collaboration and communication with the sponsor’s cross-functional teams and Biostatistics management.

Skills:

  • Ability to work effectively in international teams and within a matrix organization, collaborating with multi-disciplinary groups.
  • Strong understanding of customer needs with the ability to respond to inquiries.
  • Excellent verbal and written communication skills, effectively working with multi-disciplinary groups.
  • Well-organized and detail-oriented, with the ability to manage multiple tasks and meet deadlines.
  • Strong time management and organizational skills.
  • Brings creative ideas and suggestions for process optimization.
  • Exhibits leadership and mentorship skills for the biostatistics team working on the clinical development teams.

Qualifications:

To be successful in this role, you will have:

  • A Master’s degree in statistics or a related discipline (Ph.D. strongly preferred).
  • 9+ years of experience supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • Ability to work independently, demonstrating initiative and flexibility with effective leadership.
  • Attention to detail, quality-focused, with excellent interpersonal and communication skills, innovative, and collaborative behaviors.
  • Strong proficiency in SAS programming for QC’ing critical outputs, efficacy/safety tables, and working closely with programmers.
  • Knowledge of R programming (R Shiny/Python) is a plus.

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