إحصائي حيوي

Roles and responsibilities

As a key contributor to clinical trial design and execution, you will collaborate closely with clinical teams to ensure robust and statistically sound trial methodologies. This includes working with cross-functional teams to define appropriate endpoints and selecting the most effective study designs for clinical trials. You will also be responsible for developing and overseeing statistical analysis plans (SAPs), which include key aspects such as randomization strategies, sample size calculations, and endpoint definitions. Your expertise will help ensure that the statistical methodology is aligned with regulatory expectations and that data analyses are conducted with the highest level of rigor.

In addition to planning, you will play a hands-on role in executing statistical analyses for clinical trials. This involves using advanced statistical techniques to analyze clinical trial data, interpret findings, and present your results to both internal teams and external stakeholders, including regulatory authorities. Your ability to clearly communicate complex statistical concepts will be vital in ensuring that all stakeholders understand the implications of the data and can make informed decisions.

A critical aspect of the role is ensuring the production of high-quality regulatory-compliant deliverables. You will oversee the programming, validation, and review of tables, listings, and figures (TLFs) to support the trial results and ensure consistency with regulatory requirements. Your attention to detail and ability to review these outputs for accuracy and compliance will be vital in supporting the submission process.

Desired candidate profile

Qualifications:

To be successful in this role, you should have a Master's or Ph.D. in Biostatistics, Statistics, or a related field. A strong foundation in statistical theory and practice is essential, with a specific emphasis on clinical trial methodology and analysis.

Proficiency in statistical software, particularly SAS and/or R, is required. Experience with CDISC data standards (such as SDTM and ADaM) is highly preferred, as these are critical for regulatory submissions and ensuring data consistency across trials.

Experience in the biotech or pharmaceutical industry, particularly in the context of clinical trials and regulatory submissions, is highly valuable. You should have a demonstrated ability to apply statistical methods to real-world clinical trial data and experience in the regulatory submission process.