Bio-Statistician

0-2 years

Not Disclosed

Remote

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Bio-Statistician I (0-2 years of experience)
Location: [Location not provided]
Employment Type: [Employment type not specified]
Job Category: [Category not specified]
Job Number: [Job number not provided]
Is Job Remote?: [Remote status not specified]
Country: United States

Job Overview

The Bio-Statistician I position is designed for entry-level professionals with 0-2 years of experience in statistics, particularly in the context of clinical trials and life sciences research. This role involves applying statistical methods to analyze clinical trial data, providing statistical support, and assisting with the development of study designs and statistical analysis plans.

Essential Job Responsibilities

Assist in the development of statistical analysis plans (SAP) for clinical trials, ensuring that the analysis meets regulatory requirements and study objectives.
Apply appropriate statistical methods to clinical trial data, including descriptive statistics, hypothesis testing, and regression analysis.
Work with clinical data to perform statistical analyses for interim and final reports, tables, listings, and figures.
Collaborate with biostatisticians and clinical researchers to ensure the integrity of statistical models and the interpretation of results.
Prepare and present statistical reports that summarize findings and recommendations.
Ensure that statistical analyses adhere to industry standards, such as ICH-GCP and FDA guidelines.
Participate in the review and interpretation of clinical trial data, providing insights to improve study outcomes.
Help validate statistical models and test assumptions underlying the analyses.
Maintain awareness of statistical software tools and techniques, applying them to enhance analysis processes.
Provide support in regulatory submissions, ensuring that statistical methodologies align with agency requirements.

Required Qualifications

Bachelor’s degree in Statistics, Biostatistics, Mathematics, or a related field.
0-2 years of experience in biostatistics or statistical analysis, preferably in a clinical or life sciences setting.
Proficiency in statistical software such as SAS, R, or SPSS.
Understanding of basic statistical concepts, including hypothesis testing, ANOVA, regression, and survival analysis.
Ability to interpret complex data and provide clear, concise reports.
Strong attention to detail and the ability to work with large datasets.
Good communication skills to present statistical findings to non-statistical stakeholders.
Knowledge of regulatory requirements (e.g., FDA, ICH GCP) is a plus.

Preferred Qualifications

Experience working with clinical trial data and regulatory submissions.
Familiarity with data management processes and CDISC standards (SDTM, ADaM).
Experience with advanced statistical techniques and models is a plus.

Additional Information

[Additional company and diversity-related information, if applicable.]

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Bio-Statistician

Job Description

Job Overview

Essential Job Responsibilities

Required Qualifications

Preferred Qualifications

Additional Information

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