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Biostatistician Ii Fsp

2+ 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

Job Title: Biostatistician II
Company: Cytel
Location: [Region or Specify Location]
Job Type: Full-time


Who Are You?

As a Biostatistician II, you are passionate about clinical development and statistical analysis. You are skilled in utilizing advanced statistical methods to support Phase I-IV clinical studies. Your enthusiasm motivates your team to perform at their best, and your collaborative approach makes working with clients effortless. You always push clinical development forward, striving for innovation and excellence, inspiring others to do the same.


Sponsor-Dedicated Role:

Fully embedded within one of our pharmaceutical clients, supported by Cytel, you will play a key role in driving innovation. As a Biostatistician II, you will be dedicated to one of our global pharmaceutical clients—a company at the forefront of patient treatment. This is an exciting opportunity to work autonomously, take ownership of your role, and contribute to a groundbreaking program.


Position Overview:

As a Biostatistician II, you will perform ad-hoc or exploratory analyses to support submissions or Health Authority inquiries. While exposure to regulatory work is a bonus, your ability to understand and translate regulatory questions into statistical problems, and collaborate with clinical and regulatory colleagues, is crucial.


Responsibilities:

  • Provide statistical support to clinical studies.
  • Participate in study protocol development, including study design discussions and sample size calculations.
  • Review CRFs and data review guidelines; develop statistical analysis plans (SAPs), including dataset and TLG specifications.
  • Perform statistical analyses and interpret results.
  • Prepare clinical study reports, including integrated summaries for submissions.
  • Utilize your strong communication skills to explain methodology and decision consequences to non-statistical stakeholders.

Qualifications:

To succeed in this role, you will need:

  • A Master’s degree in statistics or a related discipline (Ph.D. preferred).
  • 3+ years of experience supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • CRO experience is strongly desired.
  • Experience with sample size calculations, protocol development, SAPs, and preparing clinical study reports.
  • Proficiency in SAS programming for QCing critical outputs, efficacy/safety tables, and working closely with programmers. R programming knowledge is a plus.
  • Solid understanding of CDISC requirements for regulatory submissions.
  • Experience in ADaM specifications generation and QC of datasets.
  • Ability to build strong internal and external relationships and motivate teams.
  • Effective communication skills to explain complex methodologies and their impact.