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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 with a passion for clinical development and advanced statistical analysis, you will support Phase I-IV clinical studies. You are excited, enthusiastic, and motivate your teams to deliver excellent results while collaborating easily with clients. You are always pushing clinical development forward, striving for continuous improvement, and inspiring others to do the same.


Sponsor-Dedicated Role:

Working fully embedded within one of our pharmaceutical clients, supported by Cytel, you will be at the forefront of your client’s innovation. As a Biostatistician II, you will be dedicated to one of our global pharmaceutical clients—a company driving the next generation of patient treatments. Here, individuals are empowered to work autonomously with ownership of their roles. This is an exciting opportunity to join this new program and make a significant impact.


Position Overview:

As a Biostatistician II, you will perform ad-hoc or exploratory analyses to support submissions or Health Authority inquiries. Exposure to regulatory work experience is a bonus, especially if you can translate regulatory questions into statistical problems, collaborating effectively with clinical and regulatory colleagues.


Responsibilities:

As a Biostatistician II, your responsibilities will include:

  • Providing statistical support to clinical studies.
  • Participating in the development of study protocols, including study design discussions and sample size calculations.
  • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.
  • Performing statistical analyses and interpreting results.
  • Preparing clinical study reports, including integrated summaries for submissions.
  • Utilizing strong communication skills to present and explain methodology and decisions.

Qualifications:

To succeed in this position, 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.
  • Experience working for a CRO is strongly desired.
  • Experience in sample size calculation, protocol development, SAP creation, and preparing clinical study reports, including integrated summaries for submissions.
  • Strong SAS programming skills for QCing critical outputs, efficacy/safety tables, and working closely with programmers. Knowledge of R programming is a plus.
  • Solid understanding and implementation 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 a regional or global team.
  • Effective communication skills to explain statistical methodologies and decisions in lay terms.