Biostatistics and Statistical Programming

Rho has a history rich with clinical biostatistics and statistical programming excellence

We have proudly delivered expert statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas for over 25 years. In that time, our biostatisticians and SAS® programmers have built a reputation of excellence by being responsive and collaborative, producing quality deliverables, and maintaining the highest level of scientific integrity.

Few clinical biostatistics departments have the credentials and experience of Rho

Rho has one of the most highly educated biostatistics departments in the world. With university origins and continuing academic ties, Rho's biostatisticians also continually participate in rigorous training sessions to reinforce fundamental practices and explore cutting-edge methodologies.

The company's senior scientists enjoy close working relationships and frequent dialogues with the FDA, possess extensive regulatory experience, and have held governance roles within the Drug Information Association (DIA), American Statistical Association (ASA), and Society for Clinical Trials (SCT).

Statistical Programming provides excellence in service and efficiency

For any phase of drug development, Rho’s biostatisticians in collaboration with our statistical programmers offer comprehensive services including:
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• Design of clinical trials and product programs
• Data analysis planning [-]
  • Protocols, Statistical Analysis Plans (SAPs), integrated summary of safety and effectiveness (ISS/ISE) as well as data and display specifications
• Design and implementation of randomization systems including adaptive randomization systems [-]
  • Patient-reported outcomes, diary data, study drug tracking
• Data analyzation [-]
  • Planned analyses including designing analysis data sets, statistics, and displays
  • Interim analysis for adaptive designs and data and safety monitoring boards (DSMBs)
  • Exploratory analyses for publications, abstracts, and marketing
  • Non-clinical trial data from epidemiologic studies and pre-clinical studies
  • Mechanistic data
• Generation of efficient data display using Tables Listings Figures (TLF) library [-]
  • Tailored to client's standards
  • Double-independent validation
• Support of data and safety monitoring board [-]
  • Customized DSMB reports posted electronically via a secure Web site or hard copy
  • Independent statistician as DSMB member
• Specialized statistical consultation tailored to sponsor's needs [-]
  • Presentation at the FDA
  • 24-hour turnaround on emerging issues for manuscript or FDA review
• Customized statistical training [-]
  • Introduction to statistics
  • Statistics in oncology
  • Missing data methods
  • Adaptive designs
• Customized project services [-]
  • Creation and validation of analysis database
  • Creation and validation of data warehouse
  • RhoTABLES™: validated SAS-based software for rapid generation of accurate statistical tables and listings, including auto-validation of all data values
  • Creation of load files for hassle-free updates of your corporate Oracle Clinical, ClinTrial, or other database system
  • Creation of ISS/ISE analysis databases
  • Special project programming tailored to individual client needs

Rho's experienced professional programmers work closely with biostatisticians in the creation and validation of analysis data sets and data displays. The statistical programming team is committed to excellence in the delivery of customized, fully validated deliverables. Rho's Statistical Programmers bring education, experience, technical knowledge, and training to each project. With seasoned professionals leading our programming team and expertise throughout the department, our programming staff is equipped to completely support the requirements of any project.

Rho's clinical statistics programming team members participate in annual programming conferences and are asked to take an active role by chairing sessions or presenting papers. The team routinely attends internal SAS training courses taught by one of our programmers who formerly taught at major universities.

Why is Rho Clinical Data Management unrivaled?

Read what we’ve done to become a success story.