MMS Holdings Inc. Senior Biostatistician in Indianapolis, Indiana
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 advanced input into statistical sections and overall consistency of clinical study protocols.
Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client.
Performs senior-level reviews and is responsible for the datasets and outputs of a project. Ensures consistency with the SAP and reviews for correctness and quality.
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 clinical trial.
Performs and/or coordinates the preparation, execution, reporting and documentation of high-quality statistical analysis according to the SAP.
Responsible for the statistical considerations in FDA submissions for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), including but not limited to ISS/ISE SAP, data integration plan and oversight of all integrated analyses.
Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements.
Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers.
Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol.
Generates and reviews randomization schedules per the protocol and randomization specifications.
Works with the project management group to ensure timelines are appropriate given the scope of the project.
Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
Communicates competently and independently with client to coordinate the statistical and programming considerations of the project.
Demonstrates strong understanding of ICH guidelines, as applicable to statistics.
Practices good internal and external customer service.
Master of Science (in statistics of equivalent) with four (4) plus years relevant work experience or PhD (in statistics of equivalent) with two (2) plus years of relevant years of work experience.
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 data and using SAS to validate datasets and outputs.
Excellent mathematical and problem solving skills.
Advanced knowledge of the statistical considerations involved in drug development including hands-on experience with clinical trial data.
Strong knowledge of study designs and statistical analysis methods (e.g., GLMs, non-parametric methods, survival analysis techniques, general imputation methods, common descriptive stats).
Strong familiarity with a variety of clinical data and databases (including EDC systems)
Working knowledge of SDTM/ADaM standards (in the absence of ADaM experience, considerable experience working with analysis or derived datasets).
At least three (3) years of experience in pharmaceutical industry.
Ability to coordinate the analytical aspects of multiple projects or clinical trials at the same time.
Proficiency with MS Office applications (e.g., Word, PowerPoint and Excel).
Good interpersonal, oral, and written communication skills.
Self-motivated, hardworking, dependable, and positive team-oriented personality.
Ability to communicate effectively and provide clear directions to Statistical Programmers