Senior Pharmaceutical Biostatistician

Placements24; Noord-Kaap; Sur place; ZAR 1 000 000 - 1 800 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement contributions

Performance bonuses

Professional development & conferences

Résumé du poste

Placements24 is seeking a Senior Pharmaceutical Biostatistician for a client in Kimberley, Northern Cape. You will design, analyze, and interpret clinical trial data, collaborating with cross-functional teams to define SAPs and support regulatory submissions.

The ideal candidate holds a Master’s or PhD in Statistics or Biostatistics, with at least 7 years in biostatistics within pharma; expertise in SAS (mandatory) and R programming; strong communication and regulatory knowledge.

Qualifications

• Master's or PhD degree in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 7 years of experience in biostatistics, with pharma/biotech focus.
• Experience in statistical design and analysis of clinical trials (Phase I-IV).
• Proficiency in SAS (mandatory) and/or R.
• Familiarity with GCP and regulatory guidelines (ICH).
• Excellent analytical, problem-solving, and communication skills.

Responsabilités

• Develop SAPs for clinical trials in accordance with regulatory requirements and study protocols.
• Design clinical trials, including sample size calculations and randomization schemes.
• Perform statistical analyses of clinical trial data using SAS and R.
• Interpret statistical results and contribute to CSRs, manuscripts, and presentations.
• Collaborate with clinical teams to define study objectives, endpoints, and analysis methodologies.
• Ensure quality and accuracy of statistical outputs and documentation.
• Provide statistical guidance to project teams throughout the trial lifecycle.
• Stay updated on latest statistical methodologies and regulatory guidelines.
• Review and critique scientific literature and protocols from a statistical perspective.
• Contribute to development and standardization of statistical programming practices.

Connaissances

Biostatistics

SAS

R programming

Statistical analysis

Communication skills

Formation

Master's or PhD in Statistics/Biostatistics

Outils

SAS

R

Description du poste

About the Role

Our client, a renowned leader in pharmaceutical research and development, is seeking a highly skilled Senior Pharmaceutical Biostatistician to join their prestigious team in Kimberley, Northern Cape. This role is essential for the statistical design, analysis, and interpretation of clinical trial data, ensuring the integrity and validity of research findings. You will collaborate closely with clinical development teams, data managers, and medical writers to define statistical analysis plans, perform complex analyses, and contribute to regulatory submissions. The ideal candidate will possess a strong statistical background, extensive experience in the pharmaceutical industry, and a keen ability to translate complex statistical concepts into clear, actionable insights. Your expertise will be critical in evaluating the efficacy and safety of new drug candidates, supporting regulatory approvals, and advancing patient care through robust scientific evidence. This position offers a challenging and rewarding opportunity to work on cutting-edge pharmaceutical projects and make a significant contribution to global health outcomes. We are committed to scientific excellence and fostering an environment where statistical expertise drives innovation and decision-making. Your work will directly influence the development and success of new therapies.

Key Responsibilities

• Develop statistical analysis plans (SAPs) for clinical trials in accordance with regulatory requirements and study protocols.
• Design clinical trials, including sample size calculations and randomization schemes.
• Perform statistical analyses of clinical trial data using appropriate statistical software (e.g., SAS, R).
• Interpret statistical results and contribute to the writing of clinical study reports (CSRs), manuscripts, and presentations.
• Collaborate with clinical teams to define study objectives, endpoints, and analysis methodologies.
• Ensure the quality and accuracy of statistical outputs and documentation.
• Provide statistical expertise and guidance to project teams throughout the trial lifecycle.
• Stay updated on the latest statistical methodologies, software, and regulatory guidelines.
• Review and critique scientific literature and protocols from a statistical perspective.
• Contribute to the development and standardization of statistical programming practices.

Requirements

• Master's or PhD degree in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 7 years of experience in biostatistics, with a significant portion in the pharmaceutical or biotech industry.
• Proven experience in the statistical design and analysis of clinical trials (Phase I-IV).
• Proficiency in statistical programming languages such as SAS (mandatory) and/or R.
• Strong knowledge of statistical methodologies relevant to drug development and regulatory submissions.
• Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (e.g., ICH).
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to present complex statistical information clearly.
• Ability to work effectively in a multidisciplinary team environment.
• Experience working in the Northern Cape region is an advantage.

Benefits

• Health insurance
• Retirement contributions
• Performance bonuses
• Professional development training, conferences, and career advancement within a leading pharmaceutical organization in Kimberley