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MMS Holdings Inc. Senior Biostatistics Consultant in Mexico City, Mexico

MM S is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, 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 the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn (https://www.linkedin.com/company/mms-holdings-inc-/) .

PLEASE SUBMIT AN ENGLISH VERSION OF YOUR CV.

This is a project-based consulting position that could turn into fulltime for the right candidate. Some of responsibilities may include:

  • Generates sample size calculations appropriate for the primary endpoint and based on input from the protocol

  • 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

  • Demonstrates strong understanding of ICH guidelines, as applicable to statistics

  • Works with the project management group to ensure timelines are appropriate given the scope of the project

  • Develops and reviews statistical analysis plans (SAP). Determines appropriate analyses for clinical endpoints based on input from the protocol and the client

  • Prepares and reviews statistical methods and results sections for the clinical study report (CSR) with in-house medical writers

  • Takes initiative to suggest and implement departmental process improvements

  • Excellent understanding of SDTM and ADaM dataset structures and ensures standards are incorporated correctly into current projects

  • Communicates competently and independently with client to coordinate the statistical and programming considerations of the project

  • Generates and reviews randomization schedules per the protocol and randomization specifications

  • 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)

  • Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements

  • Works with data management team to review data collection (e.g., CRFs) and helps ensure data quality throughout the clinical trial

  • Demonstrates excellent internal and external leadership skills for projects

  • Leads projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client

  • Prepares TLG shells/specifications and programming notes based on SAP and analysis/ADaM datasets

  • Performs and/or coordinates the preparation, execution, reporting and documentation of high- quality statistical analysis according to the SAP

  • Trains via self-study and self-practice independently and explores advanced topics related to biostatistics and/or drug development

  • Creates statistical training exercises, trains new biostatisticians, and serves as a mentor

  • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician

  • Is familiar with and stays current with the latest industry practices and updated regulatory guidelines

  • 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

  • Represents self and company in a professional manner and in line with core company values

  • Practices excellent internal and external customer service, communication, and team work

  • Supports objectives and improvement efforts within department and organizationally

  • Complies with all applicable policies, procedures, and training requirements

  • Additional tasks as assigned by manager

    Requirements

  • College graduate in statistical discipline, computer science or related field, or related experience

  • Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses

  • Strong hands-on experience with clinical trial and pharmaceutical development

  • Strong programming and logic skills

  • Experience in pharmaceutical or CRO industry preferred

  • Strong SAS programming, SAS base, SAS macro experience

  • Thorough knowledge and understanding of clinical data preferred

  • Familiarity with graphical software (e.g., SigmaPlot)

  • Excellent organizational and communication skills

  • Proficiency with MS Office applications

  • Strong experience with data and production of TLGs

  • Excellent scientific writing skills

  • Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques

  • Familiarity with ISO 9001:2015 and ISO 27001:2013 standards preferred

  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements

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