Hybrid Clinical Trial Coordinator - Data-Driven Impact

Placements24; South Africa; Hybride; ZAR 900 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Medical aid

Retirement planning

Life insurance

Hybrid work model

Résumé du poste

Placements24 is seeking a Biostatistician for our client in Stellenbosch, Western Cape. The role focuses on design, analysis, and interpretation of clinical trial data, ensuring regulatory compliance and scientific validity within a hybrid work setup that blends on-site facilities with remote work.

The ideal candidate holds a Master’s or PhD in statistics/biostatistics, has 4+ years in pharma/biotech, is proficient in SAS and R, and can collaborate across clinical development, data management,

Qualifications

• Master's or PhD in statistics/biostatistics or related field.
• Minimum 4 years of biostatistics experience in pharma/biotech with clinical trials.
• Proficiency in SAS (mandatory) and R.

Responsabilités

• Design clinical trial protocols and perform sample size calculations.
• Develop Statistical Analysis Plans (SAPs) outlining analysis methods.
• Perform statistical analyses of trial data using SAS or R.
• Interpret results and prepare statistical reports for regulatory submissions.
• Mentor junior biostatisticians and contribute to the biostatistics group.

Connaissances

Biostatistics expertise

Regulatory knowledge

Formation

Master's or PhD in Statistics/Biostatistics

Outils

SAS

R

CDISC

Description du poste

Biostatistician - Clinical Trials Data Analysis

Our client, a leading biopharmaceutical company deeply involved in developing novel therapies, is looking for a skilled Biostatistician to join their dedicated team in Stellenbosch, Western Cape. This role is integral to the design, analysis, and interpretation of clinical trial data, ensuring the scientific validity and regulatory compliance of our research findings. You will collaborate closely with clinical development, data management, and regulatory affairs teams to develop statistical analysis plans, perform complex statistical analyses, and prepare statistical reports. This is a Hybrid position, offering the flexibility to work both on-site in our innovative facilities in Stellenboschand remotely, fostering a productive work-life balance. The ideal candidate possesses a strong academic background in statistics or biostatistics, extensive experience with clinical trial data, and proficiency in statistical software. This role is critical in shaping the understanding and success of our clinical development programs.

Our client, a leading biopharmaceutical company deeply involved in developing novel therapies, is looking for a skilled Biostatistician to join their dedicated team in Stellenbosch, Western Cape. This role is integral to the design, analysis, and interpretation of clinical trial data, ensuring the scientific validity and regulatory compliance of our research findings. You will collaborate closely with clinical development, data management, and regulatory affairs teams to develop statistical analysis plans, perform complex statistical analyses, and prepare statistical reports. This is a Hybrid position, offering the flexibility to work both on-site in our innovative facilities in Stellenboschand remotely, fostering a productive work-life balance. The ideal candidate possesses a strong academic background in statistics or biostatistics, extensive experience with clinical trial data, and proficiency in statistical software. This role is critical in shaping the understanding and success of our clinical development programs.

About the Role

Our client, a leading biopharmaceutical company deeply involved in developing novel therapies, is looking for a skilled Biostatistician to join their dedicated team in Stellenbosch, Western Cape. This role is integral to the design, analysis, and interpretation of clinical trial data, ensuring the scientific validity and regulatory compliance of our research findings. You will collaborate closely with clinical development, data management, and regulatory affairs teams to develop statistical analysis plans, perform complex statistical analyses, and prepare statistical reports. This is a Hybrid position, offering the flexibility to work both on-site in our innovative facilities in Stellenboschand remotely, fostering a productive work-life balance. The ideal candidate possesses a strong academic background in statistics or biostatistics, extensive experience with clinical trial data, and proficiency in statistical software. This role is critical in shaping the understanding and success of our clinical development programs.

Key Responsibilities

• Design clinical trial protocols, contributing statistical expertise to study design, sample size calculations, and endpoint selection.
• Develop detailed Statistical Analysis Plans (SAPs) outlining the methods for data analysis.
• Perform statistical analyses of clinical trial data using SAS, R, or similar statistical software.
• Interpret analysis results and prepare comprehensive statistical reports for internal stakeholders and regulatory submissions.
• Collaborate with clinical teams to ensure the integrity and quality of data collected.
• Contribute to the preparation of manuscripts for publication in peer‑reviewed journals and presentations at scientific conferences.
• Ensure all statistical activities adhere to regulatory guidelines (e.g., ICH) and internal standards.
• Provide statistical input for data monitoring committees (DMCs) and other study‑related committees.
• Stay current with advancements in statistical methodologies and their application in clinical trials.
• Mentor junior biostatisticians and contribute to the growth of the biostatistics group.

Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 4 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, with a focus on clinical trials.
• Proficiency in statistical programming languages such as SAS (mandatory) and R.
• Strong understanding of clinical trial design, data analysis techniques, and regulatory requirements.
• Experience with various statistical methods relevant to clinical trial analysis (e.g., survival analysis, longitudinal data analysis, mixed models).
• Excellent analytical, problem‑solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to explain complex statistical concepts to non‑statisticians.
• Experience working in a Hybrid work environment.
• Ability to collaborate effectively with cross‑functional teams in Stellenbosch.
• Familiarity with CDISC standards is a plus.

Benefits

Our client offers a competitive salary, performance‑based incentives, and a comprehensive benefits package including medical aid, retirement planning, and life insurance. This Hybrid role based in the vibrant university town of Stellenbosch provides an excellent work‑life balance. We are committed to your professional development, offering opportunities for training, attendance at leading conferences, and career advancement within the organization. You will work with cutting‑