Senior Biostatistician - Clinical Data Analysis

Placements24; Upington; Hybrid; ZAR 1,200,000 - 1,700,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Paid time off

Job summary

Placements24 seeks a Senior Biostatistician in Upington, Northern Cape, to lead statistical analyses for clinical trials within a hybrid work model that blends on-site collaboration with remote options. You will design SAPs, perform advanced analyses (survival, longitudinal, mixed models), and develop SAS or R code to support regulatory submissions and publications.

A Master’s or Ph.D. in Biostatistics with 5+ years in pharma/biotech is required.

Qualifications

• Master's or Ph.D. in Biostatistics or related field.
• At least 5 years in biostatistics within pharma/biotech.
• Experience with SAP/CSRs and regulatory submissions.

Responsibilities

• Design SAPs for Phase I-IV trials.
• Perform complex analyses (survival, longitudinal, mixed models).
• Develop and validate SAS/R code.
• Interpret results for reports, manuscripts, and presentations.
• Mentor junior biostatisticians and support regulatory submissions.
• Ensure adherence to ICH guidelines and regulatory requirements.
• Collaborate with data management and programming teams.

Skills

Biostatistics

Clinical trial design

Statistical analysis

Data interpretation

Education

Master's degree or Ph.D. in Biostatistics or related field

Tools

SAS

R

Job description

About the Role

Our client, a prominent pharmaceutical research company committed to evidence-based medicine, is seeking an experienced Senior Biostatistician to lead statistical analysis for clinical trials. This hybrid role, based in Upington, Northern Cape , offers a dynamic work environment that combines on-site collaboration with the flexibility of remote work. The Senior Biostatistician will be responsible for designing statistical analysis plans, performing complex statistical analyses, and interpreting data to support regulatory submissions and publications. You will be an integral part of the data sciences team, ensuring the highest standards of statistical rigor and integrity in our clinical research efforts. This is an exciting opportunity to contribute to the development of innovative treatments and make a significant impact on global health outcomes.

Key Responsibilities

• Design statistical analysis plans (SAPs) for Phase I-IV clinical trials in collaboration with clinical development teams and other stakeholders.
• Perform complex statistical analyses of clinical trial data, including survival analysis, longitudinal data analysis, and mixed-model analyses.
• Develop and validate statistical programming code using SAS or R.
• Interpret statistical results and contribute to the preparation of clinical study reports (CSRs), manuscripts, and presentations.
• Provide statistical expertise and guidance throughout the clinical trial lifecycle, from protocol design to final analysis.
• Ensure statistical methodologies and analyses comply with ICH guidelines and regulatory agency requirements.
• Collaborate with data management and programming teams to ensure data quality and integrity.
• Review statistical sections of regulatory submission documents and respond to queries from health authorities.
• Mentor junior biostatisticians and contribute to the development of departmental best practices.
• Stay current with advancements in statistical methodologies and software relevant to clinical trials.

Requirements

• Master's degree or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• A minimum of 5 years of progressive experience in biostatistics within the pharmaceutical or biotechnology industry.
• Proven expertise in clinical trial design and statistical analysis methodologies.
• Proficiency in statistical programming languages such as SAS (required) and/or R (highly desirable).
• Strong understanding of ICH guidelines and regulatory requirements for clinical data analysis and reporting.
• Excellent analytical and problem-solving skills with meticulous attention to detail.
• Exceptional written and verbal communication skills, with the ability to effectively communicate complex statistical concepts.
• Demonstrated ability to work independently and collaboratively in a hybrid team environment.
• Experience with data visualization tools is a plus.
• Ability to manage multiple projects and meet tight deadlines.

Benefits

• Highly competitive salary package and annual bonus.
• Comprehensive health, dental, and vision insurance coverage.
• Generous retirement savings plan with employer contributions.
• Paid time off and company holidays.
• Opportunities for professional development, training, and conference attendance.
• A collaborative and innovative work environment.
• Exposure to diverse therapeutic areas and cutting-edge research.