Biostatistician - Clinical Trials Data Analysis

Placements24; Stellenbosch; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary package

Medical aid

Retirement planning

Life insurance

Training and conference opportunities

Career advancement

Job summary

Placements24 is seeking a Biostatistician in Stellenbosch, Western Cape for a hybrid role. You will design trials, develop SAPs, and perform analyses using SAS and R, ensuring regulatory compliance and rigorous interpretation of results.

The role requires a Master’s or PhD in Statistics/Biostatistics with 4+ years in pharma/biotech clinical trials, plus CDISC familiarity. Collaboration with clinical, data management, and regulatory teams is essential.

Qualifications

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• Excellent analytical, problem-solving and communication skills.
• Strong understanding of clinical trial design, data analysis techniques, and regulatory requirements.

Responsibilities

• Design clinical trial protocols with statistical input, including sample size and endpoints.
• Develop Statistical Analysis Plans (SAPs) and analyses using SAS/R.
• Prepare statistical reports for internal stakeholders and regulatory submissions.
• Interpret analysis results and ensure data integrity across trials.
• Mentor junior biostatisticians and collaborate with cross-functional teams.

Skills

Analytical thinking

Communication

Problem-solving

Education

Master's or PhD in Statistics/Biostatistics

Tools

SAS

R

CDISC

Job description

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 Stellenbosch and 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-edge technologies and contribute to impactful medical advancements.
• Our client fosters a collaborative and inclusive culture, valuing diverse perspectives and rewarding dedication.
• Join a team that is passionate about using data to improve human health in the beautiful Western Cape.