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12 дней назад

Principal Biostatistician (VAX)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
India
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Principal Biostatistician (VAX) (Vaccines Biostatistics): Delivering biostatistical and programming activities across the vaccine R&D value chain, from pre-clinical and clinical studies through translational research and CMC, with an accent on study design, statistical analysis plans, and regulatory submissions. Focus on leading end-to-end study biostatistics, conducting complex exploratory analyses, producing CDISC-compliant data packages, and interpreting results for health authority questions and clinical decisions.

Location: Hyderabad, India

Company

hirify.global is a global healthcare company developing medicines and vaccines to help protect people from infectious diseases.

What you will do

  • Support vaccine clinical study design, setup, conduct, analysis, reporting, and publication.
  • Develop statistical protocol sections, sample size calculations, randomization specifications, Statistical Analysis Plans, and clinical study report deliverables.
  • Develop integrated analysis plans for safety or immunology summaries and deliver analyses for submission technical dossiers.
  • Coordinate with programmers on derived variables, quality control plans, statistical analyses, and CDISC-compliant submission data packages.
  • Perform complex exploratory and ad hoc analyses, including analyses addressing Health Authorities’ questions.
  • Communicate statistical methodology and results while collaborating with study teams, safety monitoring teams, working groups, and senior leadership.

Requirements

  • 8+ years of experience in clinical biostatistics and programming research.
  • 3–5 years of experience in vaccines, including trial designs, endpoints, and statistical methods.
  • End-to-end experience as a Study Biostatistician, including protocol development, randomization setup, Statistical Analysis Plans, analyses, study reports, and publications.
  • Experience leading programmers through e-submission statistical activities such as ISS, ISE, or ISI.
  • Programming experience in SAS and R, with knowledge of CDISC, including SDTM, ADaM, SEND, P21, define.xml, and Reviewers Guides.
  • Master’s or PhD degree in Statistics, Mathematics, or a related health science, or equivalent experience; highly effective English communication skills required.

Culture & Benefits

  • Work alongside a supportive, future-focused team focused on vaccine science and data-driven decision-making.
  • Opportunities to learn, gain experience, and share knowledge.
  • Exposure to a broad range of biostatistics and programming activities and stakeholders.
  • Collaborative, diverse, inclusive, and innovation-oriented work environment.

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