Biostatistician - Clinical Data Analysis

Placements24; Stellenbosch; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Professional development

Job summary

Placements24 is seeking an experienced Biostatistician for a fully remote role within South Africa. You will design statistical analysis plans, analyze clinical trial data using SAS and R, and interpret results for regulatory submissions and scientific publications.

A strong background in clinical trials and regulatory guidelines is essential. Requirements include a Master’s or PhD in Biostatistics, 4–6 years of experience, and proficiency in SAS (R desirable).

Qualifications

• Master's or PhD in Biostatistics or closely related field.
• 4–6 years of Biostatistician experience in pharma/biotech with clinical trial focus.
• Proficiency in SAS (required) and R (desirable).
• Knowledge of regulatory guidelines (GCP, ICH, SAHPRA, FDA).

Responsibilities

• Develop SAS/R-based SAPs for clinical trials.
• Perform statistical analyses of trial data.
• Interpret results for regulatory submissions and publications.
• Design trials, including sample size calculations and randomization.
• Prepare CSRs, regulatory submissions, and manuscripts.

Skills

Biostatistics

Clinical trial analysis

Statistical programming

Remote work

Education

Master's degree in Biostatistics

PhD in Biostatistics

Tools

SAS

R

Job description

About the Role

Our client, a prominent pharmaceutical research organization, is seeking a talented and experienced Biostatistician to join their data analytics team. This is a fully remote position, offering you the opportunity to contribute to critical clinical research from your preferred location within South Africa . You will be responsible for designing statistical analysis plans, performing complex statistical analyses on clinical trial data, and interpreting results to support regulatory submissions and scientific publications. This role requires a strong analytical mindset and a deep understanding of statistical methodologies applied in the pharmaceutical industry. We are looking for an individual who can provide robust statistical support and contribute to the scientific integrity of our client's research endeavors, ensuring high-quality data interpretation for pivotal drug development programs.

Key Responsibilities

• Develop statistical analysis plans (SAPs) for clinical trials in accordance with study protocols and regulatory guidelines.
• Perform statistical analyses of clinical trial data using SAS, R, or other statistical software.
• Interpret statistical results and collaborate with clinical teams to communicate findings effectively.
• Design clinical trials, including sample size calculations and randomization schemes.
• Prepare statistical sections of clinical study reports (CSRs), regulatory submissions, and manuscripts for publication.
• Contribute to the development of data management plans and data review processes.
• Ensure the quality and integrity of statistical analyses and data interpretation.
• Stay abreast of the latest statistical methodologies and regulatory requirements in pharmaceutical research.
• Collaborate with programming teams to develop and validate statistical programs.
• Provide statistical expertise and consultation to internal stakeholders.

Requirements

• Master's or Ph.D. in Biostatistics, Statistics, or a closely related quantitative field.
• Minimum of 4-6 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, with a strong focus on clinical trial data analysis.
• Proficiency in statistical software such as SAS (required) and R (highly desirable).
• In-depth knowledge of statistical methods relevant to clinical trials, including survival analysis, regression modeling, and mixed-effects models.
• Familiarity with Good Clinical Practice (GCP) and regulatory requirements (e.g., ICH, SAHPRA, FDA).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to explain complex statistical concepts clearly.
• Proven ability to work independently in a remote setting and manage multiple projects simultaneously.
• Experience with data visualization tools is a plus.
• Ability to collaborate effectively with cross-functional teams.

Benefits

This fully remote position offers exceptional flexibility and work-life balance. Our client provides a competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and opportunities for professional development and continuous learning. You will have the chance to work on impactful clinical research projects that contribute to the development of life-changing therapies. Our client fosters a culture of scientific rigor, innovation, and collaboration, supporting your career growth in a dynamic remote environment. Enjoy the benefits of working with a leading organization from the comfort of your home office, with excellent support systems in place.