Remote Biostatistician - Pharmaceutical Trials

Placements24; Cape Town; Hybrid; ZAR 1,499,000 - 2,499,000; Full time

Benefits offered by this job

Remote work flexibility

Competitive salary

Professional development opportunities

Collaborative environment

Impact on drug development

Job summary

Placements24 is seeking a highly skilled Remote Biostatistician to design, analyze, and interpret clinical trial data within the pharmaceutical sector. This fully remote role requires close collaboration with clinical operations, data management, and regulatory affairs teams to inform drug development decisions.

The ideal candidate holds a Master's or PhD in statistics or biostatistics, 5+ years of experience, and expertise in SAS or R, with a solid grasp of ICH, FDA, and EMA guidelines.

Qualifications

• Master's or PhD in Statistics/Biostatistics or related field.
• 5+ years of Biostatistics experience in pharma/biotech with clinical trials.
• Proficiency in SAS or R.
• Strong knowledge of ICH, FDA, EMA guidelines.
• Excellent analytical and problem-solving skills.
• Clear communication of complex statistics in a remote setting.

Responsibilities

• Design SAPs and trial protocols; perform analyses.
• Analyze clinical trial data using SAS or R.
• Interpret results and support regulatory submissions.
• Collaborate with cross-functional teams to ensure data integrity.
• Stay current with advances in statistical methods for pharma.
• Provide statistical guidance throughout drug development lifecycle.

Skills

Statistical analysis

Communication skills

Problem solving

Remote collaboration

Education

Master's or PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

About the Role

Our client is seeking a highly skilled and motivated Remote Biostatistician to play a crucial role in the design, analysis, and interpretation of data from clinical trials within the pharmaceutical sector. This is a fully remote position, offering flexibility while requiring significant collaboration with clinical operations, data management, and regulatory affairs teams. You will be responsible for developing statistical analysis plans, performing complex statistical analyses, and contributing to the interpretation of study results that inform drug development decisions and regulatory submissions. The ideal candidate has a robust understanding of statistical methodologies applied to clinical trials and is adept at communicating complex statistical concepts clearly.

Key Responsibilities

• Design clinical trial protocols, including sample size calculations and statistical analysis plans (SAPs).
• Perform statistical analyses of clinical trial data using SAS or R, ensuring accuracy and adherence to SAPs.
• Interpret statistical results and contribute to the preparation of clinical study reports, manuscripts, and regulatory submission documents.
• Collaborate with cross-functional teams to ensure data integrity and appropriate statistical methodology.
• Stay current with advancements in statistical methodologies and their application in pharmaceutical research.
• Provide statistical expertise and guidance throughout the drug development lifecycle.

Requirements

• Master's or PhD in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 5 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, with a strong focus on clinical trials.
• Proficiency in statistical software packages such as SAS or R.
• Solid understanding of clinical trial design, regulatory guidelines (ICH, FDA, EMA), and statistical principles.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to present complex statistical information effectively in a remote setting .

Benefits

• Competitive annual salary and comprehensive benefits package.
• Remote work flexibility with opportunities for professional development.
• Contribution to cutting-edge pharmaceutical research and development.
• Collaborative environment with leading experts in the field.
• Opportunity to impact the development of new therapies.