Biostatistician - Clinical Trials

Placements24; Paarl; Hybrid; ZAR 900,000 - 1,200,000; Full time

Job summary

Placements24 is seeking a highly analytical Biostatistician to support clinical trials in a hybrid role, blending in-office collaboration with remote data analysis and reporting. You will design SAPs, perform analyses in SAS or R, and interpret results to support CSRs and regulatory submissions while ensuring data quality in line with ICH guidelines.

Strong collaboration with cross-functional teams is essential.

Qualifications

• Master's or Ph.D. in Biostatistics, Statistics, or related quantitative field.
• Minimum of 4 years of experience as a Biostatistician in pharma/biotech industry.
• Proficiency in SAS or R and understanding of regulatory guidelines (ICH).
• Excellent communication and interpersonal skills for effective collaboration.

Responsibilities

• Develop statistical analysis plans (SAPs) for clinical trials, including study design and sample size calculations.
• Perform statistical analyses of clinical trial data using SAS or R.
• Interpret statistical results and contribute to CSRs and regulatory submissions.
• Collaborate with clinical teams to define data collection requirements and ensure data quality.
• Provide statistical expertise and consultation to cross-functional project teams.

Skills

Statistical analysis

Communication

Collaboration

Regulatory understanding

Education

Master's or PhD in Biostatistics or related field

Tools

SAS

R

Job description

About the Role

Our client is seeking a highly analytical Biostatistician to support their Clinical Trials research. This hybrid role allows for flexibility, combining essential in-office collaboration with remote data analysis and reporting. You will be responsible for the statistical design of clinical studies, data analysis, and interpretation of results to ensure the integrity and validity of trial outcomes. The ideal candidate possesses a strong quantitative background and experience in pharmaceutical or medical research. You will work closely with clinical researchers, data managers, and regulatory affairs teams to contribute to the development of new therapies. This role is integral to assessing the efficacy and safety of investigational products.

Key Responsibilities

• Develop statistical analysis plans (SAPs) for clinical trials, including study design and sample size calculations.
• Perform statistical analyses of clinical trial data using appropriate statistical software.
• Interpret statistical results and contribute to the preparation of clinical study reports (CSRs) and regulatory submissions.
• Collaborate with clinical teams to define data collection requirements and ensure data quality.
• Provide statistical expertise and consultation to cross-functional project teams.

Requirements

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 4 years of experience as a Biostatistician, preferably in the pharmaceutical or biotech industry.
• Proficiency in statistical programming languages such as SAS or R.
• Strong understanding of clinical trial methodologies and regulatory guidelines (e.g., ICH).
• Excellent communication and interpersonal skills for effective collaboration.

Benefits

• Competitive salary and performance bonus potential.
• Hybrid work model offering work-life balance.
• Comprehensive medical, dental, and vision insurance.
• Support for continuous learning and professional development.
• Dynamic work environment with opportunities to impact patient health.