Senior Biostatistician

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $115k - $140k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

💰 $3M Venture Round on 2011-01

Therapeutics Inc. is a drug research and development company focusing on integration of clinical and regulatory strategies, trial design, product development, and marketplace analysis. The company’s services include clinical development project management, medical monitoring, and non-clinical development such as designing and managing pharmacology and toxicology programs. Therapeutics develops drugs and devices for acne, psoriasis, melasma, excess facial hair, injectable fillers, photoaging, and onychomycosis. The company was founded in 1997 and is headquartered in San Diego, California.

📋 Description

• Leadership and Project Management of statistical aspects of assigned project portfolio • Oversight and development of statistical and programming techniques to ensure quality and on time delivery of generated results • Contribute to the writing of statistical sections of study protocols • Perform sample size calculation, develop randomization specifications • Review and provide statistical input into the development of case report forms design • Author Statistical Analysis Plans (SAPs) • Research, development and application of statistical methodologies and processes • Develop and/or review SDTM and ADaM dataset specifications • Create table and listing shells per the SAP • Generate database listings for QA audits • Assist data management and trial management team in preparing for database lock • Write and/or supervise SAS programming and QC to create SDTM and ADaM data sets • Perform statistical analyses of data and interpret results • Collaborate with medical writer in the production of integrated clinical study reports • Contribute to the regulatory submissions including development of Integrated Summaries of Safety (ISS) and Efficacy (ISE) • Interact with members of the Clinical Development Team • Participate in Clinical Development Team meetings and client meetings • Participate in departmental infrastructure building and maintain programming standards.

🎯 Requirements

• Master’s or Doctoral level degree in statistics • At least 5 years of experience performing statistical analysis and reporting for clinical trials • Thorough understanding of GCPs, FDA and ICH guidelines • Excellent problem solving, organizational, written and oral communication skills • Ability to manage multiple priorities and attention to detail • Strong computer proficiency and SAS programming skills • Knowledge of core technical and regulatory requirements • Sound experience in the design, analysis and reporting of clinical studies • Strong communication, collaboration and team working skills.