Remote Pharmaceutical Biostatistician

Placements24; Klerksdorp; Hybride; ZAR 1 200 000 - 2 000 000; Plein temps

Avantages offerts par ce poste

Remote work

Competitive salary

Health benefits

Résumé du poste

Placements24 seeks an experienced Remote Pharmaceutical Biostatistician to lead design, analysis, and reporting of clinical trials with rigorous statistics and regulatory compliance.

You will use SAS and R, collaborate with clinical teams, and contribute to CSRs and regulatory submissions in a fully remote setup.

Qualifications

• Master's or PhD in Biostatistics or closely related field.
• Minimum of 6 years of biostatistics experience in pharma/biotech with clinical trials.
• Proficiency in SAS programming and knowledge of R.
• Regulatory knowledge (ICH, FDA, EMA) and GCP familiarity.

Responsabilités

• Design clinical trial protocols with sample size calculations and SAPs.
• Perform statistical analyses of trial data using SAS, R, or similar software.
• Develop and validate statistical programs for data analysis and reporting.
• Prepare CSRs, publications, and regulatory submissions with statistical input.
• Collaborate with cross-functional teams to ensure data integrity and accuracy.

Connaissances

SAS programming

R

Formation

Master's degree in Biostatistics

PhD in Biostatistics

Outils

SAS

R

Description du poste

About the Role

Our client, a global biopharmaceutical leader renowned for its cutting-edge research and development in oncology and immunology, is seeking an experienced Remote Pharmaceutical Biostatistician. This position is fully remote, allowing you to contribute to life-changing drug development from anywhere. You will be instrumental in the design, analysis, and reporting of clinical trials, ensuring statistical rigor and adherence to regulatory standards. The ideal candidate possesses a strong quantitative background, expertise in statistical methodologies applied to clinical research, and proficiency in statistical software. We are looking for a self-motivated individual who thrives in a virtual team environment and can effectively communicate complex statistical concepts to diverse audiences, including clinical teams and regulatory agencies. Join us in shaping the future of medicine through robust statistical analysis.

Key Responsibilities

• Design clinical trial protocols, including sample size calculations, statistical analysis plans (SAPs), and endpoint definitions.
• Perform statistical analyses of clinical trial data using SAS, R, or similar statistical software.
• Develop and validate statistical programs for data analysis and reporting.
• Interpret analysis results and contribute to the preparation of clinical study reports (CSRs), publications, and regulatory submissions.
• Collaborate with clinical operations, data management, and regulatory affairs teams to ensure data integrity and accuracy.
• Provide statistical expertise and guidance throughout the drug development lifecycle.
• Stay current with advancements in statistical methodologies and regulatory guidelines in clinical trials.
• Contribute to the development of statistical standards and best practices within the organization.
• Present statistical findings and methodologies to internal teams and external stakeholders.
• Ensure compliance with all relevant regulatory requirements (e.g., FDA, EMA, SAHPRA) and Good Clinical Practice (GCP).

Requirements

• Master's or Ph.D. in Biostatistics, Statistics, or a closely related quantitative field.
• Minimum of 6 years of experience in biostatistics within the pharmaceutical or biotechnology industry, focusing on clinical trials.
• Extensive experience with SAS programming and a strong understanding of R.
• Comprehensive knowledge of statistical principles and methodologies relevant to clinical trial design and analysis.
• Familiarity with regulatory guidelines (e.g., ICH, FDA, EMA) for statistical reporting in drug development.
• Proven ability to work independently and manage multiple projects in a remote work setting.
• Excellent communication, presentation, and interpersonal skills.
• Experience with statistical aspects of Phase I-IV clinical trials.
• Detail-oriented with strong analytical and problem-solving capabilities.

Benefits

• This fully remote position offers exceptional work-life balance and the flexibility to work from anywhere.
• Our client provides a highly competitive salary, comprehensive health and retirement benefits, performance-based bonuses, and significant opportunities for professional development, including advanced training and conference participation.
• This role is based in **Klerksdorp, North West**, but operates on a fully remote basis.