Biostatistician - Clinical Trials

Placements24; Gqeberha; Hybrid; ZAR 900.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Fully remote work

Health and wellness benefits

Online courses & conferences

Retirement savings plan

Flexible working hours

Zusammenfassung

Placements24 is seeking a Biostatistician to join a remote team in South Africa. The role focuses on designing, analyzing, and interpreting clinical trial data using SAS or R, contributing to regulatory submissions and publications.

The ideal candidate holds a MSc/PhD in Statistics or Biostatistics with at least 4 years in biostatistics within pharma/biotech, and a solid grasp of CDISC SDTM/ADaM. Remote work from anywhere in South Africa is offered.

Qualifikationen

• Master's or Ph.D. in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum 4 years of biostatistics experience in pharma/biotech with clinical trials.
• Proficiency in SAS or R for analysis and reporting.
• Strong understanding of clinical trial design and regulatory requirements (ICH).
• Experience with CDISC standards (SDTM/ADaM) is a plus.

Aufgaben

• Design SAPs for clinical trials in collaboration with development teams.
• Perform SAS or R analyses for efficacy and safety across trial phases I–IV.
• Develop and validate programs for data analysis and reporting.
• Prepare reports for regulatory submissions, publications, and internal reviews.
• Provide statistical guidance across the trial lifecycle from protocol to close-out.
• Contribute to protocol design and TNLD for trials and CSR tables/figures.
• Collaborate with data management to ensure data quality and integrity.
• Stay updated on statistical methodologies in clinical trials.

Kenntnisse

SAS

R

Biostatistics

Data analysis

Clinical trials

Ausbildung

MSc/PhD in Statistics/Biostatistics

Tools

CDISC SDTM/ADaM

Jobbeschreibung

About the Role

Our client, a globally recognized pharmaceutical research organization, is actively seeking a skilled Biostatistician to join their expanding team. This is a fully remote position, offering the flexibility to work from anywhere within South Africa. The Biostatistician will play a crucial role in the design, analysis, and interpretation of data from clinical trials, contributing to the development of innovative new therapies. This role demands strong statistical expertise, proficiency in statistical software, and a deep understanding of clinical trial methodologies. The ideal candidate will be passionate about leveraging data to drive scientific discovery and improve patient outcomes, working in a remote-first culture that emphasizes collaboration and efficiency. This is an exceptional chance to influence the direction of pharmaceutical research from the comfort of your home.

Key Responsibilities

• Design clinical trial statistical analysis plans (SAPs) in collaboration with clinical development teams.
• Perform statistical analyses of clinical trial data using SAS or R, including efficacy and safety analyses.
• Develop and validate statistical programs for data analysis and reporting.
• Interpret statistical results and prepare reports for regulatory submissions, publications, and internal reviews.
• Provide statistical expertise and guidance throughout the clinical trial lifecycle, from protocol development to study close-out.
• Contribute to the design of clinical trial protocols, ensuring appropriate statistical methodology.
• Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs).
• Collaborate with data management teams to ensure data quality and integrity.
• Stay current with advancements in statistical methodologies and their application in clinical trials.

Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a closely related quantitative field.
• Minimum of 4 years of experience in biostatistics within the pharmaceutical or biotechnology industry, focusing on clinical trials.
• Proficiency in statistical programming languages such as SAS (preferred) or R.
• Strong understanding of clinical trial design, methodologies, and regulatory requirements (e.g., ICH guidelines).
• Experience in analyzing data from various phases of clinical trials (Phase I-IV).
• Excellent analytical and problem-solving skills, with the ability to communicate complex statistical concepts clearly.
• Proven ability to work independently and manage multiple projects effectively in a remote setting.
• Experience with CDISC standards (SDTM, ADaM) is a significant advantage.
• Must be authorized to work in South Africa and comfortable working remotely.

Benefits

• Competitive annual salary of R .
• Fully remote work arrangement, offering significant flexibility.
• Generous health and wellness benefits package.
• Opportunities for continuous learning and professional growth through online courses and conferences.
• Collaborative and supportive remote team culture.
• Contribution to impactful clinical research projects.
• Retirement savings plan.
• Work-life balance encouraged through flexible working hours.