Statistician

Role: Statistician with Clinical Experience Location: Remote Job Description: We are seeking a highly qualified Statistician with a PhD in Statistics or a closely related field, possessing extensive experience in clinical trials and specialised expertise in predictive biomarkers for subgroup identification. The successful candidate will play a pivotal role in designing and optimising advanced statistical trial methodologies, including umbrella trials, and contribute to the strategic development of drug dosing, timing, and combinations. This role also encompasses conducting meta-analyses to inform trial assumptions and performing comprehensive data pulls for benchmarking across scientific literature and regulatory documentation. Key Responsibilities • Design and implement innovative statistical methodologies for clinical trials, including advanced trial designs such as umbrella trials. • Utilise predictive biomarkers to identify and define patient subgroups for targeted therapeutic strategies. • Optimise drug dosing, timing, and clinical end-points combination regimens through robust statistical modelling and analysis. • Conduct meta-analyses to develop and refine assumptions for clinical trial protocols and statistical plans. • Perform systematic data pulls and benchmarking across peer-reviewed publications, scientific abstracts, and FDA documents to support evidence-based decision-making. • Collaborate effectively with cross-functional teams including clinicians, regulatory experts, and data scientists to ensure alignment of statistical strategies with clinical objectives. • Prepare clear, comprehensive reports and presentations for internal stakeholders and external regulatory submissions. Required Qualifications • Possess a PhD in Statistics, Biostatistics, or a closely related quantitative field, along with over five years of experience as a statistician/data scientist in clinical research. • Demonstrated experience in designing and analyzing clinical trials, preferably within the pharmaceutical or biotechnology sectors. • Advanced expertise in predictive biomarker analysis for subgroup identification. • Proficiency in developing and applying innovative statistical trial designs, including umbrella trials. • Strong capability in optimizing drug dosing, timing, and combinations using statistical methodologies. • Hands-on experience in meta-analysis and evidence synthesis for clinical research. • Proficient in data extraction and benchmarking from diverse sources such as publications, abstracts, and regulatory documents. • Excellent communication skills with the ability to present complex statistical concepts to both technical and non-technical audiences. Preferred Skills • Familiarity with regulatory requirements and statistical standards for clinical trial submissions (e.g., FDA, EMA). • Expertise in statistical programming languages (such as R, SAS, or Python). • Experience in working within multidisciplinary teams in a global setting. • Strong publication record in peer-reviewed journals. Regards, Bharath Kumar bharath.k@themesoft.com