Senior Biostatistician - Clinical Trials

Placements24; Sandton; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Annual bonus

Health and dental insurance

Remote work stipend

Flexible working hours

Professional development

Job summary

Placements24 seeks a Senior Biostatistician for a fully remote role with a leading pharmaceutical research organization. You will design, analyze, and report on clinical trials across therapeutic areas, developing SAPs and supporting regulatory submissions from a remote location in South Africa.

You will work with clinical scientists, data managers and medical writers, mentor junior statisticians, and stay up-to-date with regulatory guidelines.

Qualifications

• Master’s or PhD in Biostatistics or related field.
• 5–7 years in biostatistics with clinical trial focus.
• Proficiency in SAS and/or R required.
• Knowledge of regulatory requirements (ICH, FDA, EMA) is essential.

Responsibilities

• Develop SAPs for clinical trials.
• Design trial protocols with appropriate sample size considerations.
• Analyze data using SAS, R, and prepare TFLs for reports.
• Collaborate with clinical operations, data management and medical writing teams.
• Mentor junior biostatisticians and contribute to statistical programming.
• Stay current with regulatory guidelines and industry best practices.

Skills

SAS/R programming

Clinical trial analysis

Statistical methods

Remote work

Data interpretation

Education

Master's or PhD in Biostatistics or Statistics

Tools

SAS

R

Job description

About the Role

Our client, a forward-thinking pharmaceutical research organization, is actively seeking a highly skilled Senior Biostatistician to join their fully remote team. This position is integral to the design, analysis, and reporting of clinical trials across various therapeutic areas. You will be responsible for developing statistical analysis plans, performing complex statistical analyses, and interpreting results to support regulatory submissions and clinical decision-making. The ideal candidate will possess a strong foundation in statistical theory and extensive experience applying these principles to clinical trial data. As a remote-first company, we offer a collaborative and flexible work environment where your expertise can make a significant impact. You will work closely with clinical scientists, data managers, and medical writers to ensure the integrity and validity of trial outcomes. This role demands a high degree of analytical rigor, problem-solving skills, and excellent communication capabilities to effectively convey complex statistical concepts. We are looking for an individual passionate about leveraging data to drive advancements in medicine and enhance patient care. Your contributions will be critical to the success of our client's drug development programs. This is an exciting opportunity to advance your career in biostatistics within a supportive and innovative setting.

Key Responsibilities

• Develop statistical analysis plans (SAPs) for clinical trials, defining the statistical methodology for analyzing study data.
• Design clinical trial protocols, ensuring appropriate sample sizes and statistical considerations are incorporated.
• Perform complex statistical analyses using SAS, R, or other statistical software, ensuring accuracy and efficiency.
• Interpret statistical results and prepare tables, figures, and listings (TFLs) for clinical study reports and regulatory submissions.
• Collaborate with clinical operations, data management, and medical writing teams throughout the trial lifecycle.
• Provide statistical input for study protocols, case report forms (CRFs), and other study-related documents.
• Contribute to the development and validation of statistical programs and tools.
• Stay current with statistical methodologies, regulatory guidelines, and industry best practices.
• Participate in cross-functional team meetings and present statistical findings.
• Mentor junior biostatisticians and contribute to the team's technical development.

Requirements

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 5-7 years of relevant experience in biostatistics, with a significant focus on clinical trial analysis within the pharmaceutical or biotech industry.
• Proficiency in statistical programming languages such as SAS and/or R is essential.
• Solid understanding of clinical trial design, statistical principles, and regulatory requirements (e.g., ICH, FDA, EMA).
• Experience in analyzing data from Phase I-IV clinical trials.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, with the ability to explain complex statistical concepts to non-statisticians.
• Demonstrated ability to work independently and collaboratively in a remote team environment.
• Experience with statistical modeling and survival analysis is a plus.
• Familiarity with data visualization tools is advantageous.

Benefits

• Highly competitive salary package.
• Annual bonus opportunities based on performance.
• Comprehensive health, dental, and vision insurance.
• Generous 401(k) or equivalent retirement plan with employer match.
• Substantial paid time off and flexible working hours.
• Home office stipend and reimbursement for essential equipment.
• Access to advanced statistical software and computational resources.
• Professional development and conference attendance support.