Position Duties and Responsibilities
Arog Pharmaceuticals, Inc. is a fast-growing oncology-focused biopharmaceutical company located in Dallas, Texas. We are recruiting for a Biostatistician to provide support as the project statistician on a team or within a therapeutic area. For one or more projects, you will be accountable for statistical aspects of protocols and submissions including quality. You will participate in preparation of statistical strategy, implementing study designs, statistical models and analysis methodologies by establishing the efficacy and safety of the drug. Moreover, you will be accountable of overseeing external vendors for outsourced activities with responsibilities related to quality, budgets and timelines related to allocated studies.
Specific responsibilities may include, but are not necessarily limited to:
• Design clinical trials and provide sound statistical guidance on clinical development projects
• Review of study protocol and preparation of statistical methodologies
• Provide sample size estimates for proposed studies
• Oversee and monitor CRO performance on implementation of SAP
• Write statistical section of study protocols, statistical analysis plans and study reports
• Review and consult on CRF design
• Develop clinical trial randomization
• Review study protocols, CRFs, database structures, edit check specifications, analysis plans, study reports and annual reports
• Lead study or project team in the review and discussion of SAP
• Maintain study documentation of statistical analyses and supportive documents
• Other duties as assigned
Qualifications:
• PhD degree in Statistics, Biostatistics or related field, and at least two years of relevant experience, or Masters degree in Statistics, Biostatistics or related field, and at least four years of relevant experience
• At least 3 year’s experience as Statistician in Pharmaceutical industry with experience in ONCOLOGY
• Proficient with SAS programming and other statistical software (e.g., R, nQuery)
• An ability to be productive and successful in a collaborative work environment
• Good communication skills – written and verbal
• Excellent interpersonal, verbal and written communication skills are essential
• Comfortable in a small to mid-sized company environment with minimal direction and able to adjust workload based upon changing priorities
• Extensive knowledge of statistics applied to clinical studies
• Demonstrable knowledge of international standards (ICH, GCP, CDISC) and regulations related to clinical studies
• Extensive knowledge in management and oversight of external vendors
Send cover letter and current resume to mpurilechner@arogpharma.com