PPD Senior Data Analyst – (CDISC Programmer) - Peri- and Post Approval Studies (PPAS) in Waltham, Massachusetts
SENIOR DATA ANALYST – (CDISC PROGRAMMER) – PERI-AND POST APPROVAL STUDIES (PPAS)
*We are looking to fill this role in Waltham, MA and Bethesda, MD; h owever, we will consider other remote based locations, depending on candidate’s experience
The Senior Data Analyst will perform advanced statistical programming activities for a variety of clinical and non-interventional research projects. Works independently in a lead analyst role on studies of moderate to high complexity. Provides training and guidance to junior team members.
This individual will create the data specifications, create Analysis Data Model (ADaM) datasets, and conduct all required programming to execute the Statistical Analysis Plan (SAP). Studies will consist of a variety of both prospective and retrospective studies, leveraging primary and secondary data sources or a combination thereof, as well as clinical trial data. The main programming language is SAS (e.g., SAS Enterprise Guide, SAS Stat, SAS Macro). The Sr Data Analyst implements a broad range of analyses working with little or no supervision to generate data specifications, ADaM datasets, and analyses output (tables, listings, figures).
This individual will also be required to provide input in the development of programming budgets, and planning and designing phases of projects with the project teams. The Sr Data Analyst will work closely with the internal project team (Project Manager, Principal Investigator, Statistician, etc.), as well as the sponsor team where appropriate.
Essential Duties and Responsibilities (other duties may be assigned):
Acts as the lead analyst on selected studies of moderate to high complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines for programming and analyses. Assumes leadership responsibility as a contributing member of a multi-disciplinary project team, communicating actively and frequently with other team members as needed.
Reviews and provides critical input into SAPs, study reports, and other relevant documentation for internal or external communication.
Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.
Implements or oversees implementation of data manipulation, cohort selection, variable derivation, analyses, and production of results (tables, listings, and figures), including validation and review of others' programs, all per RWE good programming practices.Creates specifications for validation programmer.
Implements ADaM by following best practices and industry standards.
Provides training and guidance to junior team members.
Ensures adherence to departmental working practice documents and SOPs; adapts these where needed to ensure alignment with PPAS needs. Contributes to the creation of programming standards and training for other Data Analysts to build out the ADaM skillset in the team.
Provides general infrastructure support to the department, including presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies. Contributes to a library of SAS Macros to increase programming efficiency.
Contributes to budget development in regard to planning programming effort.
Participates effectively on client calls and addresses questions related to the implementation of the protocol/SAP.
Presents to internal teams and suggests alternative approaches towards analyses, documentation, and general process improvements.
Works closely with the statistician in execution of complex statistical analyses.
Education, Professional Skills & Experience:
Education fields: Statistics, Biostatistics, Computational science, Epidemiology, Health Economics, or related field with extensive programming experience
PhD with at least 3 years of relevant work experience; MSc with at least 5 years of relevant work experience; Bachelors with at least 7 years of relevant experience.
Comprehensive understanding of CDISC standards, implementing ADaM and specs.
Computer programming or software skills required: Advanced knowledge of SAS Base or Enterprise Guide, SAS macro, and Microsoft Excel, Word, PowerPoint, Access and Outlook.
Experience with real-world data, pharmacoepidemiological research and CRO experience would be considered an asset.
Personal Skills & Competencies:
Communicates and documents information effectively in written English, including the ability to produce reports, documents, emails and other written pieces which are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience.
Effective communication and interpersonal skills including the ability to:
quickly develop and sustain positive rapport with internal contacts in person, over the phone and by email.
train and oversee peers and junior staff on skill building and quality of work.
Analyzes, responds to, and resolves enquiries, issues and escalations.
Proactive and positive approach to tasks and projects, as well as resilience when encountering process, project, budget or client changes that are inherent in the consulting environment.
Evidera is a business within in Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.
We offer a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.
Evidera’s Core Competencies:
If you resonate with our core competencies and want to contribute to research and consulting services driven by world-class science and thought leadership, then please submit your application – we’d love to hear from you.
Evidera, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, sexual orientation, gender preference, disability, or status as a qualified individual with a disability or protected veteran.
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