Clinical Trials Biostatistician

**Posting Start Date**:28/02/2025

**Job Summary**
Key Responsibilities**Study Design & Statistical Analysis**
- Assist in developing comprehensive statistical analysis plans (SAPs), including defining trial endpoints, sample size calculations, and analysis methods.
- Conduct advanced statistical analyses using SAS, R, or Python to evaluate clinical trial outcomes and ensure robust conclusions.
- Support the randomization process and provide statistical input on trial design to ensure methodological rigor and alignment with regulatory standards.
- Perform interim and final analyses, carefully addressing missing data, covariates, and statistical nuances relevant to biomarker-driven studies.

**Data Management & Quality Control**
- Collaborate with data management teams to ensure the accuracy and quality of clinical trial data, particularly in studies involving liquid biopsies, genomic and proteomic profiling, and high-throughput technologies.
- Conduct rigorous data cleaning, validation, and exploratory data analysis (EDA) to identify meaningful patterns and trends in complex datasets.
- Work closely with clinical teams to identify and resolve data discrepancies, ensuring the integrity of the dataset for downstream analysis.

**Regulatory & Scientific Communication**
- Contribute to the preparation of statistical reports, clinical study reports (CSRs), and regulatory submissions (e.g., to FDA, EMA) that meet high scientific and regulatory standards.
- Provide statistical justifications during regulatory interactions, ensuring that the trial design, analysis, and results are robust and scientifically sound.
- Assist in preparing manuscripts, presentations, and abstracts for publication in high-impact international journals and presentation at leading scientific conferences.

**Collaboration & Teamwork**
- Work in close collaboration with a multidisciplinary team of clinicians, researchers, and data managers to support the overarching goal of discovering novel cancer biomarkers and therapeutic targets.
- Provide statistical support and expertise during investigator meetings, data review sessions, and other collaborative efforts focused on cancer pharmacology and functional genomics.
- Engage in continuous learning and contribute ideas to refine statistical methodologies and enhance the clinical trial process in line with emerging cancer research trends.

**Special Focus on Cancer Research**
- Work closely with the research team focused on cancers of the upper aerodigestive tract (head and neck and lung cancers) to understand genetic polymorphisms, somatic mutations, and therapeutic targets for precision oncology.
- Analyze data from ongoing studies focused on plasma-based biomarker discovery, such as liquid biopsies for NSCLC and nasopharyngeal carcinomas (NPC).
- Contribute to novel research in the development of targeted therapies, including inhibitors of oxidative phosphorylation (OXPHOS), STAT3 signaling, and cell cycle regulation, as well as cancer immunotherapy.

**Qualifications**

**Essential**:

- Master’s degree or PhD in Biostatistics, Statistics, Epidemiology, or a related field.
- Experience or training in clinical trial design and analysis (Phase I-IV), especially in cancer-related clinical research.
- Proficiency in statistical software (SAS, R, or Python) for data analysis, modeling, and visualization.
- Strong knowledge of ICH-GCP, FDA, EMA, and other regulatory guidelines specific to biostatistics and clinical trials.
- Excellent analytical, problem-solving, and communication skills, with a keen ability to present complex statistical concepts to non-statistical audiences.

**Preferred**:

- Prior experience in the pharmaceutical, biotech, contract research organization (CRO), or academic research settings, especially in oncology or cancer-related clinical trials.
- Knowledge of advanced statistical methods such as survival analysis, mixed models, Bayesian statistics, or machine learning approaches.
- Familiarity with real-world data (RWD) or observational studies, particularly in oncology.

**Benefits & Opportunities**
- Competitive salary and benefits package.
- Training and mentorship from senior biostatisticians and cancer research experts.
- Opportunities for career growth, professional development, and exposure to cutting-edge cancer research.
- Collaboration on high-impact research aimed at improving cancer detection, treatment options, and patient outcomes in a dynamic, supportive environment.

This is a unique opportunity to be part of a world-class research team at the forefront of cancer pharmacology, genomics, and precision oncology. If you have a passion for statistical analysis in clinical trials and a desire to make a tangible impact on cancer research and treatment, we encourage you to apply.