Associate Director Biostatistics

DNA Life Sciences; Málaga; Presencial; EUR 50.000 - 90.000; Jornada completa

Descripción de la vacante

An established industry player in life sciences is seeking a skilled biostatistician to lead innovative oncology clinical trials. In this pivotal role, you will harness your expertise to design and analyze complex studies, ensuring compliance with regulatory standards while driving forward the latest advancements in clinical research. Collaborate with a dynamic team of clinicians and researchers to contribute to groundbreaking projects that shape the future of healthcare. If you are passionate about making a significant impact in the field of oncology, this opportunity is tailor-made for you.

Formación

• 5+ years of experience in biostatistics, focusing on oncology clinical trials.
• Strong knowledge of ICH-GCP, FDA, and EMA regulations.

Responsabilidades

• Lead large projects and ensure alignment with strategic goals.
• Oversee data analysis initiatives and develop new methodologies.

Conocimientos

Biostatistics

Oncology Clinical Trials

Statistical Analysis

Data Management

Bayesian Methods

SAS

R Programming

Survival Analysis

Clinical Research Regulations

Machine Learning

Educación

Bachelor's Degree in Life Sciences

Herramientas

SAS

R

CDISC Standards

Clinical Data Management Tools

Python

Descripción del empleo

• Participate and contribute to the development of new projects by providing expertise in design and statistical assumptions.
• Possesses in-depth knowledge of the latest clinical research trends and developments. Demonstrates a strong understanding of the global landscape and its implications for clinical research.
• Leads large projects involving complex project dynamics and ensuring alignment with strategic goals.
• Improves quality assurance activities. Consistently demonstrates a high level of attention to details and documentation management.
• Leads risk management activities / projects; monitors and reports on risk status and effectiveness of controls.
• Oversees data analysis initiatives; develops new methodologies and tools for data management.
• Participate in meetings with internal and external stakeholders in the discussion / defence of new study design contributing with data science expertise
• Participate and oversee in the development of Study Protocols by providing statistical input and data specifications.
• Design and oversee eCRF design and structure to ensure that it meets the specific requirements defined in the study protocol.
• Development and / or oversee Data Science Plan for assigned projects.
• Define or review randomization procedures and produce randomization lists.
• Development and review of Statistical Analysis Plans.
• Perform and / or supervise programming of tables, listings, figures, derived datasets, and statistical analyses according to agreed timelines and quality standards.
• Perform and / or supervise quality control of statistical output produced by other members of the department or external providers, including tables, listings, figures, derived datasets, and statistical analyses.
• Define criteria for different populations for the analysis (e.g., Safety, ITT, PP) and perform the programming for the implementation of the criteria.
• Plan and perform statistical analysis (interim and / or final) in accordance with the Study Protocol and the Statistical Analysis Plan.
• Validation of the defined statistical methods (by e g goodness-of-fit tests or model checking).
• Document and validate programs and files for analysis.
• Manage clinical data to ensure security and confidentiality.
• Produce statistical reports.
• Assist in writing / reviewing the statistical sections in the study report.
• Collaborate with other team members : clinicians, clinical researchers, operations, data management and software programmer.
• Review and provide input in interpreting analysis results to clinical study report.
• Contribute to clinical development of plan preparation.
• Assist in performing / review sample size calculations.
• Participation in international multi-stakeholder advisory boards.
• Contributes to the departmental strategy and goals, to ensure alignment with overall company strategy and goals

Requirements :

• A bachelor’s degree in Life Science (Biology, Biotechnology, Biomedicine, Statistics...).
• Minimum 5 years of experience in biostatistics, with a focus on oncology clinical trials, especially in Phase III studies.
• Design of Phase I-IV clinical trials, basket, umbrella, and adaptive trials in oncology.
• Survival analysis methods (Kaplan-Meier, Cox models, hazard ratios, landmark analysis).
• Advanced statistical methodologies :
• Application of Bayesian methods and predictive modeling in oncology.
• Statistical analysis of biomarker data and precision medicine.
• Experience with patient-reported outcomes (PROs) and composite endpoints.
• Proficiency in SAS and R for advanced statistical analysis.
• Experience with CDISC standards (SDTM, ADaM) and dataset validation for regulatory submissions.
• Familiarity with clinical data management tools (EDC, IRT).
• Knowledge of Python for exploratory analysis and machine learning applications in oncology.
• Strong knowledge of ICH-GCP, FDA, and EMA regulations and oncology-specific statistical guidelines.
• Experience in preparing and defending statistical packages for regulatory submissions.
• Participation in regulatory meetings (eg : Advisory Boards).
• Preparation of responses to regulatory queries and support in FDA / EMA interactions.
• Implementation of statistical methodologies to evaluate efficacy, safety, and benefit-risk per regulatory requirements.