Job Description

Hi,

Please check the job description as below and let me know you if you would be interested and available. Please let me know your available time for a quick call.

Statistician Clinical Trials & Predictive Biomarkers

Chicago, California & New Jersey

PhD Must.

6+ Months

Required Qualifications

• Possess a PhD in Statistics, Biostatistics, or a closely related quantitative field, along with over five years of experience as a statistician 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.

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 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.

Isaac Rajiv

Kutir Corporation

Ph: 510 201 7068

Rajiv@Kutir.onmicrosoft.com

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