Biostatistician - Clinical Trials Design

Placements24; Cape Town; Sur place; ZAR 900 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Medical/dental/vision insurance

Retirement savings plan

Paid time off

Relocation assistance

Résumé du poste

Placements24 seeks a Biostatistician to join a pioneering pharmaceutical R&D team in Cape Town. You will design endpoints, sample sizes, and randomization schemes for clinical trials and provide SAPs and robust analyses using SAS, R, and SPSS.

You will mentor junior staff, ensure GCP compliance, and contribute to regulatory submissions and publications, supporting life-saving medical research from Cape Town.

Qualifications

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.

Responsabilités

• Design statistically sound clinical trial protocols with endpoints, sample sizes, and randomization schemes.
• Develop SAPs detailing methods for trial data analysis.
• Perform complex statistical analyses on clinical trial data using SAS, R, or SPSS.
• Interpret results and prepare regulatory submission reports and publications.
• Provide statistical expertise to investigators and study teams.
• Ensure compliance with GCP, FDA/EMA guidelines and internal SOPs.
• Critically review literature and proposals for statistical validity.
• Contribute to development and validation of statistical methods.
• Assist in manuscript preparation for journals and conferences.
• Mentor junior biostatisticians and programmers.

Connaissances

Biostatistics

Clinical trial design

Survival analysis

Longitudinal analysis

SAS

R

CDISC SDTM/ADaM

Regulatory knowledge

Statistical programming

Communication

Formation

Master's or PhD in Biostatistics or related

Outils

SAS

R

SPSS

Description du poste

About the Role

Our client, a pioneering force in pharmaceutical research, is seeking a dedicated Biostatistician to join their esteemed scientific R&D team in Cape Town. This critical position will focus on the statistical design and analysis of clinical trials, ensuring the integrity and validity of research findings. You will play a crucial role in shaping study protocols, advising on data collection methodologies, and providing robust statistical analysis for groundbreaking therapeutic developments. The successful candidate will possess a deep understanding of statistical principles applied to biological and medical research, with a proven ability to collaborate effectively with cross-functional teams, including clinicians, data managers, and regulatory affairs specialists. This role offers the chance to contribute to life-saving medical advancements from our beautiful Cape Town base.

Key Responsibilities

• Collaborate with clinical research teams to design statistically sound clinical trial protocols, defining endpoints, sample sizes, and randomization schemes.
• Develop statistical analysis plans (SAPs) that clearly outline the methods for analyzing trial data.
• Perform complex statistical analyses on clinical trial data using various statistical software packages.
• Interpret study results and prepare statistical reports for regulatory submissions, scientific publications, and internal review.
• Provide statistical expertise and consultation to investigators, study coordinators, and other research personnel.
• Ensure compliance with Good Clinical Practice (GCP), regulatory guidelines (e.g., FDA, EMA), and internal SOPs.
• Critically review scientific literature and internal research proposals for statistical validity.
• Contribute to the development and validation of statistical methods and programming tools.
• Participate in the preparation of manuscripts for peer-reviewed journals and presentations at scientific conferences.
• Manage and mentor junior biostatisticians and statistical programmers.

Requirements

• Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 4 years of progressive experience in biostatistics, with a significant focus on clinical trial design and analysis.
• Strong knowledge of statistical methodologies relevant to clinical trials, including survival analysis, longitudinal data analysis, and categorical data analysis.
• Proficiency in statistical software such as SAS, R, or SPSS.
• Familiarity with CDISC standards (SDTM, ADaM) and their application in clinical research.
• Understanding of regulatory requirements and guidelines for clinical trials.
• Excellent written and verbal communication skills, with the ability to explain complex statistical concepts to non-statisticians.
• Proven ability to work independently and as part of a multidisciplinary team.
• Experience in therapeutic areas such as oncology, cardiology, or infectious diseases is a plus.
• Detail-oriented with a strong commitment to data accuracy and scientific rigor.

Benefits

• This position offers a competitive salary, a comprehensive benefits package including medical, dental, and vision insurance, and a retirement savings plan.
• Opportunities for professional growth, including attendance at relevant scientific conferences and workshops, are provided.
• Our client values work-life balance and offers generous paid time off.
• Being part of our Cape Town team means contributing to impactful research within a supportive and innovative environment.
• We are committed to fostering a diverse and inclusive workplace where your contributions are recognized and rewarded.
• Relocation assistance may be considered for exceptional candidates.