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Biostatistician

5+ years
Not Disclosed
10 Jan. 23, 2025
Job Description
Job Type: Remote Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Senior Biostatistician
Location: India, Remote
Employment Type: Permanent
Job Posting Date: April 22, 2024

Job Overview:

As a Senior Biostatistician, you will leverage advanced statistical techniques to support and lead Phase I-IV clinical studies. Your primary focus will be across various therapeutic areas, including Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, and Medical Affairs. You will provide comprehensive statistical support, interpret results, and ensure the successful execution of clinical trials.

Key Responsibilities:

  • Provide statistical support to clinical studies, ensuring all analyses are robust and accurate.
  • Review analysis datasets and efficacy TLFs (tables, listings, and figures).
  • Perform complex statistical analyses using appropriate methodologies.
  • Interpret statistical results and provide insights into clinical trial outcomes.
  • Prepare detailed clinical study reports, including integrated summaries for regulatory submissions.
  • Communicate statistical methodologies and results effectively, explaining the implications of decisions in lay terms to stakeholders.
  • Collaborate with multidisciplinary teams to ensure project goals are met and deadlines are achieved.
  • Demonstrate flexibility and adaptability in response to evolving project needs.

Preferred Skills & Experience:

  • Strong written and verbal communication skills, with the ability to present complex statistical concepts clearly.
  • Proficiency with moderately complex statistical methods applicable to Phase I-IV clinical trials.
  • Demonstrated ability to manage multiple tasks and meet deadlines.
  • Familiarity with statistical software and tools commonly used in clinical trials (e.g., SAS, R).

Education & Experience:

  • Minimum Education: Master’s degree in Statistics, Biostatistics, or a related health science field.
  • Minimum Experience: At least 5 years of statistical experience in clinical trials or health research environments.

Additional Skills:

  • Strong organizational and problem-solving skills.
  • Ability to work independently and as part of a team, demonstrating leadership and mentorship when needed.
  • In-depth knowledge of clinical trial methodologies and regulatory guidelines.

This position offers an exciting opportunity to apply statistical expertise to impactful clinical research projects, contributing to the development of new therapies and treatments