Remote Biostatistician - Statistical Programming

Our client, a distinguished global pharmaceutical research organization, is seeking a highly skilled Remote Biostatistician with a strong background in statistical programming to join their innovative team. This fully remote position offers the flexibility to work from anywhere in South Africa, contributing to pivotal clinical trials that advance global healthcare. You will be responsible for the design, analysis, and reporting of clinical trial data, ensuring statistical rigor and accuracy.

The ideal candidate will possess advanced statistical knowledge and expertise in programming languages commonly used in biostatistics. This is an exceptional opportunity to apply your analytical talents in a dynamic, remote-first environment, collaborating with leading researchers and contributing to the development of life-changing therapies. Your statistical insights will be crucial in interpreting trial results and supporting regulatory submissions.

• Design statistical analysis plans (SAPs) for clinical trials in collaboration with clinical development teams.
• Develop, program, and validate statistical programs using SAS or R for data analysis.
• Perform statistical analyses of clinical trial data, including efficacy, safety, and exploratory endpoints.
• Interpret analysis results and prepare statistical reports and summaries for internal stakeholders and regulatory submissions.
• Ensure adherence to statistical principles, regulatory guidelines (e.g., ICH), and company SOPs.
• Collaborate with data management, clinical operations, and medical writing teams.
• Provide statistical input on study design, sample size calculations, and protocol development.
• Review statistical outputs generated by other team members and vendors.
• Stay current with statistical methodologies, software, and regulatory expectations.
• Contribute to the continuous improvement of biostatistics processes and standards.

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 4 years of experience as a Biostatistician in the pharmaceutical or biotechnology industry, with hands-on statistical programming experience.
• Proficiency in SAS (Base, Stat, Macro) or R for statistical analysis and data manipulation.
• Strong understanding of clinical trial design, statistical methodologies, and regulatory requirements.
• Excellent analytical and problem-solving skills.
• Effective written and verbal communication skills, with the ability to explain complex statistical concepts clearly.
• Ability to work independently and manage multiple projects in a remote setting.
• Experience with CDISC data standards (SDTM, ADaM) is highly desirable.
• Detail-oriented and committed to producing high-quality, accurate statistical results.
• Team player with good interpersonal skills.

This remote position offers a competitive salary, comprehensive health benefits, a retirement savings plan, and opportunities for professional growth through advanced training and virtual conferences. Our client emphasizes a healthy work-life balance, offering flexible working hours and generous paid time off. Join a globally respected pharmaceutical organization and contribute to significant advancements in healthcare, all while enjoying the flexibility of remote work from your preferred location in South Africa.