CDISC Validation Statistician

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ManTech International
Analyst, Management, Protocols, Statistical Analysis, SAS, Computer, Biotechnology, Programmer, SQL, FDA, Analytical
Full Time
Work from home not available Travel not required

Job Description

Secure our Nation, Ignite your Future
Analyzes factors and components of systems to recommend and institute changes to increase efficiency. Plan studies of work problems and procedures, such as organizational changes, communication, information flow, integrated production methods, or cost analysis. Recommends improvements of modifications in sequence of operations, equipment utilization and related matters. Examines and analyzes current and contemplated operations for developing, defining, and coordinating user requirements which will satisfy the total program need. Translates user requirements into system specifications, configuration management plans, life cycle management documentation, and integrated logistics support plans and related operational summaries. Writes specifications manuals and user documentation for client or user personnel. Gathers information from users, defines work problems, and designs a system and procedures to resolve problems. May supervise and provide technical direction to lower level Functional Analyst. Requires Bachelor's Degree in related field or equivalent experience and five to seven years of related experience.Basic Program Overview:
ManTech is multi-billion-dollar public company that provides the innovation, adaptability, and critical thinking our government needs for success in health, science, defense, intelligence, law enforcement, and other fields. ManTech is seeking a person to work in an energetic military medical research organization. You will work with senior epidemiologists and bio-statisticians, physicians and military personnel, to design, execute, analyze, and report epidemiological studies of military personnel. This position requires Those authorized to work in the United States without sponsorship are encouraged to apply.ship.

General Responsbilites:
  • Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, Statistical Analysis Plans, etc.) and trial conduct.
  • Identify data trends and report study inconsistencies to applicable study team personnel and work together to develop and implement an action plan.
  • Implement data standard and create SDTM data.
  • Maintains client contacts to ensure conformity to all contractual obligations.
  • Be involved in writing and implementing grants and contracts and RFPs that enable expanding the data analytics, AI, predictive modeling portfolio.
  • Lead validation efforts by comparing modeling predictions with outcomes of research.
  • Experienced in advanced epidemiologic study design and analyses of computerized datasets. Strong computer skills in using SAS, Epi-info, and graphical packages.
  • Will develop and deliver department analytical reports and give oral/visual presentations to professional groups. May travel to meetings and conferences when necessary.
  • Perform validation of CDISC SDTM data in accordance with SOPs and guidance documents.
  • Develop quantitative epidemiological models using data from a variety of sources.
  • Conduct quality review, data cleaning, merging, and extraction of relevant information from multiple large data sets.
  • Produce clear and concise written reports documenting the methodology used to conduct and analyze epidemiological studies.
  • Conduct literature and abstract searches from conferences regarding changes in epidemiological methods.
  • Be prepared to develop independent research projects.
  • Ensure SDTM data conforms to the data standards expected by regulatory agencies.

  • Mandatory Skills:
  • Bachelors degree in Statistics, Mathematics, or Computer Science or in a related field.
  • Minimum of 4 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
  • Demonstrate proficient working knowledge of CDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
  • Demonstrated knowledge of ICH/GCP guidelines as they relate to data management.
  • Thorough understanding of CDISC CDASH and SDTM standards.
  • Experience with SAS at a higher level, including SAS macro language, SAS and STAT, and SAS and GRAPH.
  • Experience with DATA Step and SQL processing, CDISC standards, or data management for large datasets, including ETL.
  • Significant experience in applying statistical techniques including linear, logistic and conditional logistic regression models, survival analyses, proportional hazards, and other types of multivariate statistical models.
  • Proven proficiencies in SAS, including macros and SQL, and ArcGIS for statistical analysis, as well as a strong knowledge of the Microsoft Office suite.
  • Published in peer-reviewed journals for descriptive and risk factor epidemiological studies and a policy assessment of the disability evaluation process.
  • Knowledge in military preventive medicine issues, military populations and structure, and reasons for disability, including traumatic brain injury, psychological disorders, musculoskeletal injuries and asthma.
  • Active NACI security clearance.
  • Must be able to interpret and apply statistical techniques, and to explain methods and findings to non-statistician research team members.
  • Please provide writing sample (article, manuscript, research paper, etc).
  • Strong communication skills, interpersonal, negotiation, consensus-building, and analytical skills

  • Degrees:
    Equivalent ExperienceEducation,Bachelors Degree,See Qualifications

    Skills:
    Ability to handle stress and work well under pressure,Analytical and Critical Thinking Skills,Interpersonal and People Skills,Leadership Skills,Listening Skills,Oral and Written Communication Skills

    ManTech International Corporation, as well as its subsidiaries proactively fulfills its role as an equal opportunity employer. We do not discriminate against any employee or applicant for employment because of race, color, sex, religion, age, sexual orientation, gender identity and expression, national origin, marital status, physical or mental disability, status as a Disabled Veteran, Recently Separated Veteran, Active Duty Waretime or Campaign Badge Veteran, Armed Forces Services Medal, or any other characteristic protected by law.

    If you require a reasonable accommodation to apply for a position with ManTech through its online applicant system, please contact ManTech's Corporate EEO Department at (703) 218-6000. ManTech is an affirmative action/equal opportunity employer - minorities, females, disabled and protected veterans are urged to apply. ManTech's utilization of any external recruitment or job placement agency is predicated upon its full compliance with our equal opportunity/affirmative action policies. ManTech does not accept resumes from unsolicited recruiting firms. We pay no fees for unsolicited services.

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access http://www.mantech.com/careers/Pages/careers.aspx as a result of your disability. To request an accommodation please click careers@mantech.com and provide your name and contact information.


    Company Information

    ManTech was founded in 1968 to provide advanced technological services to the United States government. We began with a single contract with the U.S. Navy to develop war-gaming models for the submarine community. Over the years, our government's technology needs have increased dramatically in scope and sophistication, and we have grown to meet that challenge.
    Dice Id : 10120503
    Position Id : 104681BR
    Originally Posted : 4 months ago

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