Biostatistician Ii - Non-Clinical

5-8 years

Not Disclosed

India Remote

10 Feb. 7, 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: Biostatistician II - Non-clinical

Job ID: R0000029701
Category: Biostatistics
Location: India, Remote
Date Posted: 01/24/2025

Role Overview:

The Biostatistician II - Non-clinical position involves contributing to statistical strategies and providing statistical expertise for bioanalytical and pharmacokinetic studies. This position will focus on supporting non-clinical bioanalytical assay development, GLP, and non-GLP drug safety studies.

Key Responsibilities:

Study Design and Development:
- Contribute to the design of studies, including bioanalytical assays, pharmacokinetic studies, and drug safety studies.
- Develop study protocols, statistical analysis plans (SAP), trial designs, and case report forms (CRFs).
Statistical Leadership:
- Lead the production and quality control of randomization, statistical analysis plans, statistical reports, and statistical sections of integrated clinical reports.
- Ensure the quality and integrity of statistical outputs for nonclinical and clinical studies.
Sample Size and Randomization:
- Perform sample size calculations for studies.
- Generate randomization lists for trials and studies.
- Write statistical methodology sections for inclusion in study protocols.

Qualifications:

Education:
- PhD or Master’s degree in Statistics or a related discipline.
Experience:
- 5-8 years of relevant experience in bioanalytical and pharmacokinetic studies.
Skills:
- Expertise in statistical strategies for bioanalytical assay development.
- Familiarity with GLP and non-GLP drug safety studies.
- Experience in protocol development, study design, and statistical reporting.
- Proficient in performing sample-size calculations, generating randomization lists, and writing statistical methodology sections for study protocols.

Additional Information:

Remote Role: This is a remote position, providing flexibility in work location.

Let me know if you'd like to adjust or expand on any section!

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Biostatistician Ii - Non-Clinical

Job Description

Job Title: Biostatistician II - Non-clinical

Role Overview:

Key Responsibilities:

Qualifications:

Additional Information:

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