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Bio-Statistician I

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Remote 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: Bio-Statistician I

Experience Level: 0-2 Years

Application Email: careers@clinztech.com


Job Summary

ClinzTech is seeking a Bio-Statistician I to support statistical analysis and data management activities in clinical trials and biomedical research. This entry-level role is ideal for recent graduates or professionals with up to 2 years of experience in biostatistics, statistical programming, and clinical research. The selected candidate will work closely with biostatisticians, SAS programmers, data managers, and clinical teams to ensure the integrity and accuracy of statistical analyses.

This position offers an excellent opportunity to gain hands-on experience in clinical trial design, statistical methodologies, and regulatory compliance.


Key Responsibilities

Statistical Analysis & Data Interpretation

  • Assist in designing statistical analysis plans (SAPs) for clinical trials.
  • Perform descriptive and inferential statistical analyses using SAS, R, or Python.
  • Support sample size calculations, hypothesis testing, and modeling for clinical studies.
  • Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs).

Regulatory Compliance & CDISC Standards

  • Ensure adherence to CDISC standards (SDTM, ADaM) and regulatory guidelines (FDA, EMA, ICH-GCP).
  • Assist in preparing statistical reports and documentation for regulatory submissions.
  • Support quality control (QC) and validation of statistical outputs.

Collaboration & Research Support

  • Work closely with clinical teams, SAS programmers, and data managers to ensure high-quality data analysis.
  • Provide statistical input in protocol development and study design.
  • Participate in internal and external statistical meetings to discuss study findings.

Qualifications & Requirements

Education:

  • Master’s degree in Biostatistics, Statistics, Mathematics, Epidemiology, or a related field.
  • Candidates with a Bachelor’s degree and strong statistical programming skills may also be considered.

Experience:

  • 0-2 years of experience in biostatistics, clinical research, or statistical analysis.
  • Exposure to clinical trial methodologies and study design is preferred.

Technical Skills:

  • Proficiency in statistical software (SAS, R, or Python).
  • Basic knowledge of clinical data structures and CDISC standards (SDTM, ADaM).
  • Understanding of machine learning techniques and predictive modeling is a plus.

Soft Skills:

  • Strong analytical and problem-solving abilities.
  • Excellent written and verbal communication skills.
  • Ability to work collaboratively in a team-oriented environment.

Preferred Qualifications

  • Internship or coursework experience in biostatistics, clinical trials, or epidemiology.
  • Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP).
  • Knowledge of Bayesian statistics and survival analysis is a plus.

Benefits & Growth Opportunities

  • Competitive entry-level salary with performance-based incentives.
  • Comprehensive health, dental, and vision insurance.
  • Opportunities for career advancement and professional development.
  • Training and mentorship programs from senior biostatisticians.
  • A collaborative work environment with exposure to cutting-edge clinical research.

How to Apply

Interested candidates should email their CVs to careers@clinztech.com with the subject line: Bio-Statistician I Application – [Your Name].

For more information about ClinzTech, visit Company Website.