Hybrid (onsite 3 days a week/2 days WFH/remote). Collaborate with clinical teams to develop study design & protocol, including statistical methodology & sample size determination. Ensure studies are designed to meet regulatory & scientific standards. Perform statistical analyses of clinical trials. Interpret results in context of clinical objectives. Prepare statistical sections of study documents, including Statistical Analysis Plan (SAP), clinical study reports, & regulatory submissions. Provide clear & comprehensive reports that comply with regulatory requirements. Act as a statistical consultant to clinical teams. Ensure adherence to industry standards, company policies, & regulatory guidelines. Conduct quality checks & audits of statistical analysis processes and outputs to uphold data quality and reliability.
Must have a PhD in Statistics, Biostatistics, or a highly related field, & must have 2 years of experience in each of the following: (i) identifying data or analytical issues, and assisting with providing solutions; (ii) developing & utilizing statistical tools for conducting meta-analysis; and (iii) performing statistical computations and simulations. Must also have experience in: (i) designing, analyzing, and reporting clinical or research studies in the biotech or pharmaceutical industry; and (ii) performing drug development and life-cycle management in the regulated environment. Work experience may be gained concurrently.
Apply online at https://careers.abbvie.com/en or send resume to [email protected]. Refer to Req ID: REF49664K.
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