MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn .

Roles Responsibilities

• Provides input into statistical sections of the clinical study protocol.
• Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client .
• Reviews output and datasets to ensure consistency with the SAP and reviews for correctness and quality. Writes SAS programs to validate outputs as needed.
• Works with programming team to provide definitions for analysis/ADaM datasets to be used for final analyses. Develops specifications and reviews datasets based on what is needed for the planned tables, listings and graphs (TLGs).
• Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets.
• Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the study.
• Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
• Independently familiarizes self with statistical practices in the industry and explores advanced topics related to biostatistics and/or drug development.
• Serves as statistical resources to the programmers and medical writers on all statistical matters as appropriate.
• Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
• Reviews analysis datasets and TLGs to ensure quality, accuracy and consistency with the SAP.
• Generates and reviews randomization schedules per the protocol and randomization specifications.
• Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
• Demonstrates understanding of ICH guidelines, as applicable to statistics.
• Practices good internal and external customer service.

Requirements

• At least 2 years of experience with a Master of Science (in statistics of equivalent) or PhD (in statistics of equivalent).
• Strong knowledge of and experience with SAS (SAS Stat, SAS Base, SAS macros, SAS/ODS, SAS/Graph).
• Able to be in a hands-on role by digging into the data and using SAS to validate datasets and outputs.
• An understanding of the statistical considerations in drug development.
• Hands-on experience with clinical trial and pharmaceutical development.
• Experience with clinical or life science data (a working knowledge of SDTM/ADaM standards is preferred).
• Experience producing and reviewing summary outputs (i.e., TLGs).
• Keeps up-to-date with statistical knowledge, trends, and applications.
• Experience in pharmaceutical or CRO industry preferred.
• Familiarity with visual displays and graphical output. Experience with graphical software (e.g., SigmaPlot) preferred.
• Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
• Self-motivated, organized, hardworking and team-oriented.
• Ability to communicate effectively and provide clear directions to Statistical Programmers.