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Biostatistician

1-5 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: Biostatistician
Location: India, Remote
Employment Type: Permanent
Posting Date: July 10, 2024


Position Overview:

As a Biostatistician, you will provide expert statistical support for Phase I-IV clinical studies, specializing in areas such as Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. Your primary responsibilities will include performing statistical analyses, preparing clinical study reports, reviewing analysis datasets, and ensuring accurate interpretation of results. Your ability to communicate complex statistical concepts clearly and work effectively in a team environment will be essential to your success in this role.


Key Responsibilities:

  • Statistical Support for Clinical Studies:
    • Provide statistical guidance and support for Phase I-IV clinical trials.
    • Perform statistical analyses to support the study objectives and interpret results.
    • Review analysis datasets and ensure the accuracy of efficacy TLFs (tables, listings, and figures).
  • Clinical Study Reporting:
    • Prepare and assist in writing clinical study reports, including integrated summaries for regulatory submissions.
    • Communicate complex statistical methodology and results to non-statistical team members and stakeholders, explaining the implications of decisions in lay terms.
  • Team Collaboration:
    • Collaborate effectively with cross-functional teams, providing expertise on statistical methods and ensuring quality and consistency.
    • Demonstrate flexibility and adaptability when priorities change and deadlines approach.

Required Knowledge, Skills, and Abilities:

  • Technical Expertise:

    • Proficiency in statistical methods applied to clinical trials.
    • Strong working knowledge of SAS and other relevant statistical computing packages (such as R or STATA).
    • Familiarity with relevant data standards, including CDISC/ADaM.
  • Regulatory Knowledge:

    • In-depth understanding of clinical research regulations, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Communication Skills:

    • Excellent written and verbal communication skills, including technical and grammatical writing capabilities.
    • Ability to present statistical concepts clearly to both technical and non-technical audiences.
  • Organizational and Problem-Solving Skills:

    • Strong attention to detail and the ability to manage multiple tasks and projects efficiently.
    • Ability to solve moderately complex problems independently and work with teams to find solutions.
  • Leadership and Teamwork:

    • Ability to coordinate small teams and lead initiatives.
    • Strong initiative and the ability to work collaboratively in a team setting.

Minimum Required Education and Experience:

  • Education:
    • PhD in Biostatistics or a related field with 1 year of relevant experience; or
    • Master's degree in Biostatistics or a related field with 3 years of relevant experience; or
    • Bachelor's degree in Biostatistics or a related field with 5 years of relevant experience; or
    • Equivalent combination of education, training, and experience.

How to Apply:

Interested candidates are encouraged to submit an updated resume highlighting relevant experience and qualifications.


This is a remote position offering an exciting opportunity to contribute to clinical trials across multiple therapeutic areas while working in a dynamic and collaborative environment.