Senior Biostatistician

🔥 15 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $120k - $140k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 $3M Venture Round on 2011-01

Biotechnology • Healthcare • Pharmaceuticals

Therapeutics Inc. is a drug research and development company focusing on the integration of clinical and regulatory strategies, trial design, product development, and marketplace analysis in the field of dermatology. The company provides services such as clinical development project management, medical monitoring, and non-clinical development, including pharmacology and toxicology programs. It develops drugs and devices targeting conditions like acne, psoriasis, melasma, excess facial hair, injectable fillers, photoaging, and onychomycosis. Founded in 1997 and headquartered in San Diego, California, Therapeutics Inc. stands out as a full-service dermatology CRO that takes products from concept to approval.

📋 Description

• Lead and manage the statistical aspects of assigned project portfolios • Oversee and develop statistical and programming techniques to ensure quality and timely delivery of results • Contribute to statistical sections of study protocols • Perform sample size calculations • Develop randomization specifications, plans, and schedules • Review statistical input into case report forms, annotated case report forms, and database documentation • Author Statistical Analysis Plans for studies and project deliverables • Research, develop, and apply statistical methodologies and processes • Develop, review, and provide input into SDTM and ADaM dataset specifications • Create table and listing shells according to SAPs • Generate database listings for database QA audits • Assist data management and trial management teams with database lock preparation • Write or supervise SAS programming and QC for SDTM and ADaM datasets, tables, figures, and listings for clinical study reports • Perform statistical analyses and interpret results • Collaborate with medical writers on integrated clinical study reports • Contribute to regulatory submissions, including ISS and ISE development and responses to regulatory questions • Interact with Clinical Development Team members to support client satisfaction • Participate in Clinical Development Team and client meetings • Help build departmental infrastructure, programming standards, SAS macro and program libraries, and workload forecasts

🎯 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 clinical data management and analysis requirements under GCPs, FDA, and ICH guidelines • Excellent problem-solving, organizational, written, and oral communication skills • Ability to manage multiple priorities with strong attention to detail • Strong computer proficiency • SAS programming skills • Experience implementing CDISC standards end-to-end • Ability to perform statistical analyses of clinical data and prepare written interpretations of statistical results • Knowledge of core technical and regulatory requirements • Experience in the design, analysis, and reporting of clinical studies • Strong communication, collaboration, and teamwork skills

🏖️ Benefits

• Equal employment opportunities • Collaborative, diverse, and respectful work culture • Continuous learning and professional growth opportunities