Biostatistician (Clinical Data Analysis)

Placements24; Gqeberha; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive Salary

Medical Aid

Retirement Fund

Professional Development

Job summary

Placements24 is seeking a highly skilled Biostatistician for a leading pharmaceutical research organization in Port Elizabeth. The role centers on design, analysis, and reporting of clinical trial data to ensure robust and compliant findings.

You will collaborate with clinical operations and data management teams to translate complex data into actionable insights that guide drug development and patient care, applying SAS or R and adhering to ICH/FDA/EMA guidelines.

Qualifications

• Master's or PhD in Statistics, Biostatistics, or related quantitative field.
• Minimum of 5 years' experience in biostatistics, preferably in pharma/biotech.
• Proficiency in SAS or R is mandatory.

Responsibilities

• Collaborate with clinical development teams to define statistical analysis plans for trials.
• Design clinical trial protocols, considering endpoints and methodologies.
• Perform statistical analyses using SAS, R, or similar software.
• Develop and validate statistical programs for data analysis.
• Prepare statistical reports for regulatory submissions and publications.

Skills

Biostatistics

Clinical trial design

Regulatory understanding

Communication

Education

Master's/PhD in Statistics/Biostatistics

Tools

SAS

R

Job description

About the Role

Our client, a prominent pharmaceutical research organization, is seeking a highly skilled Biostatistician to join their dedicated team. This role is pivotal in the design, analysis, and reporting of clinical trial data, ensuring the integrity and validity of research findings.

The position is based in Port Elizabeth, Eastern Cape, ZA , and requires a strong presence at the office for close collaboration with the clinical operations and data management teams. You will play a key role in translating complex data into actionable insights that inform critical decisions about drug development and patient care.

Key Responsibilities

• Collaborate with clinical development teams to define statistical analysis plans for clinical trials.
• Design clinical trial protocols, considering statistical methodologies and endpoints.
• Perform statistical analyses of clinical trial data using SAS, R, or similar statistical software.
• Develop and validate statistical programs for data analysis.
• Interpret analysis results and prepare statistical reports for regulatory submissions and publications.
• Contribute to the development of tables, listings, and figures (TLFs).
• Ensure statistical methodologies comply with regulatory guidelines (e.g., ICH, FDA, EMA).
• Provide statistical expertise and support to study teams throughout the trial lifecycle.
• Stay updated with the latest advancements in statistical methodologies and software.
• Present statistical findings to internal stakeholders and external audiences.

Requirements

• Master's degree or Ph.D. in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 5 years of experience in biostatistics, preferably within the pharmaceutical or biotechnology industry.
• Proficiency in statistical programming languages such as SAS or R is mandatory.
• Solid understanding of clinical trial design and statistical methodologies.
• Experience with regulatory requirements for statistical analysis and reporting.
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication skills, with the ability to explain complex statistical concepts clearly.
• Ability to work effectively in a collaborative team environment.
• Familiarity with CDISC standards is a plus.

Benefits

• We offer a competitive salary, comprehensive medical aid, and retirement fund contributions.
• Opportunities for professional development and career advancement are abundant within our growing organization.
• You will work in a modern facility with access to advanced analytical tools and technologies.
• Our client fosters a culture of scientific rigor and collaboration, ensuring you are part of a team making significant contributions to healthcare.