Biostatistician - Clinical Trials

Placements24; Roanoke (VA); Remoto; USD 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Fully remote work

Professional development opportunities

Diverse project exposure

Flexible working hours

Collaborative virtual team

Descrizione del lavoro

Placements24 seeks an experienced Biostatistician to join a fully remote team designing, analyzing, and reporting clinical trials. You will ensure statistical rigor and support regulatory submissions, working closely with cross-functional teams in a flexible, global setting.

The role emphasizes advanced statistical methodologies, trial design expertise, and the ability to communicate complex concepts to non-statisticians in a remote environment.

Competenze

• Master's or Ph.D. degree in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 5 years of experience in biostatistics, with a strong focus on clinical trial design and analysis in the pharmaceutical or biotechnology industry.
• Proficiency in SAS or R with diverse statistical techniques.

Mansioni

• Design clinical trial protocols, including sample size calculations and randomisation schemes.
• Perform statistical analyses of trial data using SAS or R.
• Interpret results and contribute to CSRs and manuscripts.
• Collaborate with clinical operations, data management, and medical affairs teams.
• Provide statistical input for regulatory submissions and health authority interactions.
• Stay updated with advances in statistical methods for trials.

Conoscenze

Statistical design

Regulatory knowledge

Team collaboration

Remote communication

Formazione

Master's or PhD in Biostatistics

Strumenti

SAS

R

Descrizione del lavoro

About the Role

Our client is seeking a highly skilled Biostatistician to join their fully remote team, contributing to the design, analysis, and reporting of clinical trials. This role is critical in ensuring the statistical integrity and rigour of studies evaluating new therapeutics. You will work closely with clinical development teams, applying advanced statistical methodologies to interpret trial data and support regulatory submissions. This is an ideal opportunity for an experienced biostatistician to leverage their expertise in a flexible, remote setting while making a significant impact on drug development and patient outcomes.

Key Responsibilities

• Design clinical trial protocols, including sample size calculations, randomisation schemes, and statistical analysis plans.


• Perform statistical analyses of clinical trial data using statistical software packages such as SAS or R.


• Interpret analysis results, contribute to the preparation of clinical study reports (CSRs), and assist in the development of manuscripts for publication.


• Collaborate with clinical operations, data management, and medical affairs teams to ensure data quality and timely analysis.


• Provide statistical expertise for regulatory submissions, responding to queries from health authorities.


• Stay current with advancements in statistical methodology and their application in clinical trials.

Requirements

• Master's or Ph.D. degree in Biostatistics, Statistics, or a related quantitative field.


• Minimum of 5 years of experience in biostatistics, with a strong focus on clinical trial design and analysis in the pharmaceutical or biotechnology industry.


• Proficiency in statistical software such as SAS or R, including experience with various statistical techniques (e.g., regression, survival analysis, longitudinal data analysis).


• Thorough understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements for clinical trials.


• Excellent communication and interpersonal skills, with the ability to explain complex statistical concepts clearly to non-statisticians in a remote environment.

Benefits

• Competitive salary and comprehensive benefits package, fully remote.


• Opportunities for professional development and continuous learning in statistical methodologies.


• Exposure to a wide range of clinical development projects and therapeutic areas.


• Flexible working hours and the ability to work from anywhere.


• Collaborative and supportive virtual team environment.