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2-5 years
Not Disclosed
10 Dec. 6, 2024
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
Department: Biostatistics
Location: Delhi (Office-Based)
Employment Type: Full-Time


Job Summary

Join Insignia, a full-service Clinical Research Organization (CRO) specializing in pharmaceutical research, as a Biostatistician. This pivotal role involves designing, analyzing, and interpreting clinical trial data while ensuring adherence to the highest statistical standards.


Key Responsibilities

  • Collaborate with clinical researchers, data managers, and medical writers to design robust clinical trials.
  • Develop and implement Statistical Analysis Plans (SAPs) following regulatory guidelines.
  • Perform advanced statistical analyses and create outputs, including tables, listings, and figures.
  • Provide statistical input for protocols, CRFs, and study-related documents.
  • Conduct sample size and power calculations for study designs.
  • Validate datasets to ensure accuracy and adherence to study requirements.
  • Write and optimize SAS programs for clinical data analysis.
  • Implement CDISC standards for SDTM mapping and ADaM dataset creation.
  • Automate data manipulation and analysis through advanced programming skills.
  • Interpret statistical results and communicate findings to stakeholders.
  • Support regulatory submissions by preparing statistical sections and responding to queries.
  • Stay updated on emerging statistical methodologies, tools, and industry regulations.
  • Ensure project timelines and deliverables are met with exceptional quality.

Qualifications and Requirements

Education

  • Master’s or Ph.D. in Biostatistics, Statistics, or a related field.

Experience

  • 2–5 years in a similar role within the pharmaceutical, biotechnology, or CRO industry.
  • Hands-on experience with clinical trial data and knowledge of ICH-GCP and regulatory guidelines.

Technical Skills

  • Expertise in statistical programming (SAS, R, Python).
  • Proficiency in statistical software (e.g., SPSS, Stata).
  • Familiarity with CDISC standards (SDTM, ADaM) and data mapping.
  • Knowledge of SQL is a plus.
  • Solid understanding of clinical trial methodologies and statistical techniques.

Soft Skills

  • Exceptional problem-solving and analytical abilities.
  • Excellent communication and interpersonal skills to collaborate effectively with diverse teams.
  • High attention to detail with the ability to manage multiple tasks and deadlines.

How to Apply

Send your CV and cover letter to careers@insigniacs.com with the subject line:
“Application for Biostatistician Position.”