Senior Biostatistician

Placements24; Durban; On-site; ZAR 900,000 - 1,800,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Generous vacation

Relocation assistance

Professional development

Diverse therapeutic exposure

Job summary

Placements24 invites applications for a Senior Biostatistician based in Durban, KwaZulu-Natal, to design and analyze clinical trial data ensuring robust study conclusions. You will support regulatory submissions and collaborate with cross-functional teams to advance drug development.

The role requires a Master’s or PhD in Biostatistics and a minimum of 5 years in the pharmaceutical or biotechnology sector, with proficiency in SAS, R, and related tools.

Qualifications

• Master's or PhD in Biostatistics or closely related field.
• Minimum 5 years of biostatistics experience in pharma/biotech.
• Proficiency in SAS, R, or S-PLUS.
• Familiarity with regulatory guidelines (ICH, FDA).

Responsibilities

• Design clinical trial SAPs in collaboration with clinical teams.
• Perform statistical analyses of trial data using SAS, R, or other software.
• Interpret results and provide clear reports and visualizations.
• Contribute to study protocol design with robust statistics.
• Review and validate statistical programming outputs for accuracy.
• Ensure analyses comply with regulatory requirements and company standards.
• Prepare statistical sections for regulatory submissions (INDs, NDAs).
• Stay current with statistical methodologies in pharmaceutical research.
• Mentor junior statisticians and provide statistical guidance.
• Participate in cross-functional meetings to provide statistical input.

Skills

Biostatistics expertise

Statistical analysis

Regulatory awareness

Communication skills

Team collaboration

Education

Master's or PhD in Biostatistics

Tools

SAS

R

S-PLUS

Job description

About the Role

Our client, a distinguished leader in the pharmaceutical industry, is seeking to appoint a highly analytical and proficient Senior Biostatistician to join their esteemed team based in Durban, KwaZulu-Natal. This critical role will involve the design, analysis, and interpretation of statistical data from clinical trials and other research studies. You will be instrumental in ensuring the validity and reliability of research findings, providing statistical expertise that guides critical decision-making processes for drug development. The position requires a deep understanding of statistical methodologies applied to healthcare and pharmaceutical research, working collaboratively with data managers, clinical scientists, and regulatory affairs professionals. This is an excellent opportunity to contribute to significant medical advancements within a company renowned for its commitment to innovation and quality, situated in the picturesque coastal city of Durban.

Key Responsibilities

• Design clinical trial statistical analysis plans (SAPs) in collaboration with clinical teams.
• Perform statistical analyses of clinical trial data using SAS, R, or other statistical software.
• Interpret statistical results and provide clear, concise reports and visualizations.
• Contribute to the design of clinical study protocols, ensuring appropriate statistical methodologies are incorporated.
• Review and validate statistical programming code and outputs generated by other statisticians.
• Ensure statistical analyses comply with regulatory requirements (e.g., FDA, EMA) and company standards.
• Prepare statistical sections for regulatory submissions, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Stay current with advancements in statistical methodologies and their applications in pharmaceutical research.
• Mentor and provide statistical guidance to junior statisticians and other research personnel.
• Participate in cross-functional meetings to provide statistical input on study design, data interpretation, and research strategy.

Requirements

• Master's or Ph.D. degree in Biostatistics, Statistics, or a closely related quantitative field.
• Minimum of 5 years of relevant experience in biostatistics within the pharmaceutical or biotechnology industry.
• Proficiency in statistical programming languages such as SAS, R, or S-PLUS.
• Strong knowledge of statistical methodologies relevant to clinical trial design and analysis, including survival analysis, regression modeling, and mixed-effects models.
• Familiarity with regulatory guidelines for drug development (e.g., ICH, FDA).
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication skills, with the ability to explain complex statistical concepts to non-statisticians.
• Experience with data management principles and practices is a plus.
• Ability to work effectively in a team-oriented environment and manage multiple projects simultaneously.

Benefits

• Highly competitive salary and performance-based bonus structure.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer contributions.
• Generous paid time off and professional development opportunities.
• Relocation assistance may be available for qualified candidates.
• Exposure to diverse therapeutic areas and cutting-edge research projects.
• Collaborative work environment with opportunities for career advancement.