Biostatistician - Clinical Data Analysis

Placements24; Pretoria; Hybride; ZAR 800 000 - 1 400 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Medical aid

Pension fund

Hybrid work model

Training & conferences

Résumé du poste

Placements24 is seeking a Biostatistician to join the statistical programming and analysis team in Pretoria, Gauteng. You will design SAPs, perform analyses on clinical trial data, and interpret results to support regulatory submissions and publications.

You will collaborate with clinical operations, data management, and medical affairs to ensure trial integrity, with a hybrid work model balancing office collaboration and remote flexibility.

Qualifications

• Master's or PhD degree in Statistics, Biostatistics, or a closely related quantitative field.
• Experience of 5+ years in biostatistics within pharma/biotech focusing on clinical trial data.
• Proficiency with SAS (required) and knowledge of R or similar software.
• Understanding of clinical trial design, data management, and regulatory submission processes (SAHPRA, FDA, EMA).
• Familiarity with ADaM and CDISC standards is highly desirable.

Responsabilités

• Develop and finalize SAPs for clinical trials.
• Perform statistical analyses of trial data using SAS, R or similar software.
• Generate TFLs for study reports, manuscripts and regulatory submissions.
• Provide statistical input during study design, protocol development and data review.
• Collaborate with data management to ensure data quality and integrity.
• Interpret stats results and contribute to study reports and conclusions.
• Keep up-to-date with statistical methodologies and regulatory guidelines.
• Communicate complex concepts clearly to both statisticians and non-statisticians.
• Participate in development and validation of statistical programs and macros.

Connaissances

Statistical analysis

Analytical thinking

Communication

Team collaboration

Formation

Master's or PhD in Statistics/Biostatistics

Outils

SAS

R

S-Plus

Description du poste

About the Role Our client, a leading biopharmaceutical company, is actively seeking an accomplished Biostatistician to join their esteemed statistical programming and analysis team in Pretoria, Gauteng. This critical role involves the design of statistical analysis plans, the execution of complex statistical analyses on clinical trial data, and the interpretation of results to support regulatory submissions and publications. You will collaborate closely with clinical operations, data management, and medical affairs teams to ensure the integrity and validity of clinical trial outcomes. This position offers a unique opportunity to contribute to groundbreaking research and development efforts in Pretoria, fostering innovation within a hybrid work model that balances office collaboration with remote flexibility.

Key Responsibilities

• Develop and finalize Statistical Analysis Plans (SAPs) for clinical trials, ensuring alignment with study protocols and regulatory expectations.
• Perform statistical analyses of clinical trial data using SAS, R, or other relevant statistical software.
• Generate tables, figures, and listings (TFLs) for clinical study reports, manuscripts, and regulatory submissions.
• Provide statistical expertise and input during study design, protocol development, and data review.
• Collaborate with data management to ensure the quality and integrity of clinical databases.
• Interpret statistical results and contribute to the scientific discussion and conclusions of study reports.
• Stay updated on statistical methodologies, software advancements, and regulatory guidelines relevant to clinical trials.
• Communicate complex statistical concepts clearly and effectively to both statistical and non-statistical colleagues.
• Participate in the development and validation of statistical programs and macros.

Requirements

• Master's or PhD degree in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum of 5 years of experience in biostatistics within the pharmaceutical or biotechnology industry, with a strong focus on clinical trial data analysis.
• Proficiency in statistical analysis software such as SAS (required), R, S-Plus, or similar.
• Solid understanding of clinical trial design, data management, and regulatory submission processes (e.g., SAHPRA, FDA, EMA).
• Experience with ADaM and CDISC standards is highly desirable.
• Strong analytical and critical thinking skills, with the ability to solve complex statistical problems.
• Excellent written and verbal communication skills, with the ability to present technical information effectively.
• Proven ability to work collaboratively in a team environment and manage multiple projects concurrently.
• Familiarity with various statistical techniques, including regression modeling, survival analysis, and longitudinal data analysis.

Benefits

• Our client offers a highly competitive salary and an attractive benefits package, including comprehensive medical aid, life insurance, and a pension fund.
• Employees benefit from continuous learning opportunities, including access to internal and external training, workshops, and conference participation.
• This hybrid role provides a flexible working arrangement, allowing for a healthy work-life balance.
• Located in Pretoria, the office environment is modern and collaborative.
• Opportunities for career progression and exposure to diverse therapeutic areas are significant.

Join a team that values scientific rigor and innovation in pharmaceutical research.