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MMS Holdings Inc. Associate Manager Statistical Programming in Canton, Michigan

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:

  • Departmental and Process Oversight

  • Responsible for professional development of colleagues

  • Provides leadership, mentors, and develops personnel by maintaining a positive work environment

  • Defines program testing criteria, including debugging / troubleshooting, and preservation of source codes

  • Leads and implements programming departmental process improvements

  • Demonstrates a strong understanding of CDISC standards, GCP/ ICH guidelines, and FDA regulations and ensures incorporation into departmental process improvements as needed

  • Creates department training exercises and ensures training occurs as required

  • Responsible for hiring recommendations of personnel to meet the resourcing needs of the company; working with PM to understand forecasting of resourcing needs

  • Responsible for planning and resourcing for on-time delivery of project deliverables that meet quality objectives; ensures clear communication with PM for ensuring assignment of the best fit resource

  • Works with management in other departments to develop business initiatives and process improvements across the organization; solution focused

  • Identifies future risks and provides solutions before the risks become a barrier to producing quality deliverables on time

  • Ensures the departmental goals are met and are in line with company goals

  • Deliverable Oversight

  • Travels to client sites as necessary

  • Defines and documents client specifications and ensures compliance to customer templates

  • Confers with client to confirm all specification assumptions are correct

  • Develops data and programming specifications jointly with other programmers and statisticians

  • Responsible for quality assurance to ensure programming integrity

  • Assists with resolving client concerns for programming issues as needed

  • Responsible for implementation and execution of high quality clinical programming

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

  • Interacts directly and independently with client to coordinate all facets of projects; expert communicator who has developed strong relationships with clients

  • Works with statistical team to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs (TLGs)

  • Generates tables, listings, and graphs from clinical trial databases using SAS

  • Develops programs, verifies, validates, and maintains clinical trial databases and data entry screens using SAS and related software

  • Designs specific data presentations including creative summary tables, graphs, and patient listings

  • Independently implements and validates QC findings in compliance with NC Handling Procedure

  • Conducts thorough self-review of deliverables prior to releasing to client; serves as expert reviewer for others

  • Demonstrates complete proficiency in client interactions

  • Takes initiative to suggest and implement programming improvements and follows through to completion

  • Leads projects, delegates tasks, and manages timelines, resources, budgets, clients, internal team, and deliverables independent of management

  • Fully accountable for providing highest quality deliverables to satisfy or exceed client requirements

  • Functions as a highly technical resource to the organization

  • Produces and presents external company presentations providing industry visibility for the organization

  • Builds and maintains strong client contacts and relationships

  • Continually suggesting solutions to solve issues in tune with organizational direction

Job Requirements:

  • Bachelor?s or Master?s degree in computer science, health care, or clinical programming discipline with industry or relevant experience

  • 6+ years SAS programming, SAS Base, SAS Macro experience

  • Strong programming and logic skills, including ability to program data presentations and produce TLGs

  • 2+ Year of experience leading a small team of Statistical Programmers

  • Effectively communicates with senior level contributors and managers on the sponsor side

  • Provides guidance and coaching to the individual contributor level colleagues on how to effectively resolve client's issues and concerns, while maintaining a high degree of customer service

  • Drives focus on continuous improvement among direct reports. Helps team members identify and implement process improvement specific to the team and projects

  • Decisions and problem-solving are guided by policies, procedures and business plan; receives guidance and oversight from higher level Manager

  • Develops managerial, coaching and leadership skills. Accountable for results of a small team (1-3) of individual contributors. Sets priorities for the team based on service line objectives to ensure task completion; coordinates work activities with other managers. Coordinates and supervises the daily activities of a support or operations team

  • Responsible for managing resourcing for existing projects and project pipelines. Requires significant oversight from more senior Manager to ensure resource alignment with team specific projects and project pipeline. Provides input on resource planning

  • Strong problem-solving skills

  • Experience with leading regulatory submission components is preferred

  • Excellent understanding e-submission requirements

  • Expertise in drug development as it pertains to programming; has the ability to apply drug development knowledge during production of high quality programs

  • Extensive hands-on experience with clinical trials and pharmaceutical development

  • Extensive experience with data and production of TLGs

  • Excellent programming and logic skills

  • Excellent understanding of CDISC standards and HL-7 standards

  • Extensive SAS programming, SAS Base, SAS Macro experience

  • Thorough and extensive knowledge of clinical database structures

  • Strong capabilities in programming data presentations, using program such as SAS procedures

  • Subject matter expert in SAS programming skills; willing to guide others in a variety of programming techniques

  • Expert proficiency with MS Office applications

  • Excellent organizational and communication skills

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

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

  • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.