Senior Biostatistician - Pharmaceutical R&D

Placements24; East London; Vor Ort; ZAR 900.000 - 1.400.000; Vollzeit

Benefits dieser Stelle

Health insurance

Life and disability coverage

Retirement savings plan

Professional development

Zusammenfassung

Placements24 is seeking an experienced Senior Biostatistician to join our East London, Eastern Cape team. You will provide statistical leadership for design, analysis, and reporting of clinical trials and research studies within a collaborative quantitative sciences group.

In this role, you will develop SAPs, perform advanced analyses using SAS and R, and ensure regulatory and methodological rigor. Mentorship of junior statisticians and ongoing methodological development are key components.

Qualifikationen

• Strong analytical and problem-solving skills.
• Ability to translate complex statistics for non-statisticians.
• Experience presenting results to stakeholders.

Aufgaben

• Design clinical trials and research studies with statistical input.
• Develop SAPs (Statistical Analysis Plans) for trials.
• Perform SAS/R analyses ensuring SAP adherence.
• Interpret results and collaborate with clinical teams.

Kenntnisse

Statistical analysis

Regulatory understanding

Communication

Project management

Collaboration

Ausbildung

Master's or Ph.D. in Statistics/Biostatistics

Tools

SAS

R

Jobbeschreibung

About the Role

Our client, a leading pharmaceutical research and development company, is seeking an experienced Senior Biostatistician to join their quantitative sciences team in East London, Eastern Cape . This integral role involves providing statistical expertise for the design, analysis, and reporting of clinical trials and research studies. The Senior Biostatistician will be responsible for developing statistical analysis plans, performing complex statistical analyses, and ensuring the integrity and validity of statistical findings that support drug development decisions. This position offers a stimulating environment for a statistically minded professional to contribute to the advancement of innovative pharmaceutical products. We are looking for a dedicated individual who can provide robust statistical support from our East London location.

Key Responsibilities

• Design clinical trials and research studies, providing statistical input into protocols and case report forms.
• Develop detailed Statistical Analysis Plans (SAPs) for clinical trials.
• Perform statistical analyses of clinical trial data using SAS or R, ensuring accuracy and adherence to SAPs.
• Interpret statistical results and collaborate with clinical teams to translate findings into actionable insights.
• Prepare statistical sections of clinical study reports (CSRs), regulatory submissions, and manuscripts for publication.
• Conduct exploratory data analysis and contribute to pharmacodynamic (PD) and pharmacokinetic (PK) modeling efforts.
• Ensure statistical methodologies meet regulatory requirements (e.g., FDA, EMA, SAHPRA) and industry standards.
• Review statistical outputs from external vendors and CROs.
• Mentor junior biostatisticians and contribute to the development of statistical expertise within the team.
• Stay abreast of new statistical methodologies, software, and regulatory guidelines.
• Present statistical findings and recommendations to internal stakeholders, including project teams and senior management.
• Contribute to the strategic planning of statistical activities for drug development programs in East London .

Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum of 5 years of progressive experience in biostatistics within the pharmaceutical or biotechnology industry.
• Strong proficiency in statistical analysis software, particularly SAS (required) and R (preferred).
• In-depth knowledge of statistical methodologies commonly used in clinical trial analysis (e.g., survival analysis, longitudinal data analysis, mixed models).
• Familiarity with ICH guidelines and regulatory requirements for statistical analysis in drug development.
• 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.
• Ability to manage multiple projects and prioritize effectively in a deadline-driven environment.
• Experience with statistical programming, data manipulation, and data visualization.
• Demonstrated ability to work effectively in a collaborative, cross-functional team setting.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package that includes excellent health insurance, life and disability coverage, and a valuable retirement savings plan.
• We are committed to the professional development of our employees and provide opportunities for continuous learning, attendance at key statistical conferences, and support for professional certifications.
• This role is based in our modern facility in East London , providing a stimulating and collaborative work environment where your statistical expertise will be highly valued and contribute directly to the success of our pharmaceutical pipeline.