This business-critical position provides extensive statistical and data programming support across multiple projects within the Evidence Synthesis, Modeling & Communication (EMC) – Clinical Outcome Assessment (COA) team. The EMC COA team largely designs and conducts statistical analyses of COA data, including patient-reported outcome (PRO) data, from clinical studies to support sponsor’s pharmaceutical product review by regulatory and/or health technology assessment agencies. The Senior Data Analyst is integral to the success of the organization and works closely with a variety of stakeholders to drive the delivery and quality of required programming and results tables and figures. As this role supports a regulatory environment, knowledge of good clinical practices for data management is required in order to be successful.
The individual is expected to implement a broad range of analyses according to statistical analysis plan (SAP) with little or no supervision and has substantive involvement in planning and design phases of a project under the supervision of a more senior staff member. The main programming language is SAS (e.g., SAS Base, SAS Stat, SAS Macro). In addition, this individual may also participate in psychometric assessment of COA tools and other quantitative analyses using real-world data.
Principal Duties and Responsibilities:
- Implements a broad range of data manipulations and analyses working with little or no supervision
- Substantive involvement in planning and design phases of project.
- Implements or oversees implementation of cohort selection, variable derivation, data manipulation, analyses, and production of results, including validation and review of others' programs, all per clinical good programming practices.
- Capable of preparing clinical trial study datasets (e.g., SDTM and ADaM) and related documentations to meet regulatory requirements and expectations (e.g., CDISC standards for FDA new drug application.
- Reviews and provides critical input into SAPs, study reports, and other relevant documentation for internal or external communication.
- Strong knowledge in fundamental statistical concepts and methods and familiarity with techniques such as but not limited to ANCOVA, mixed effects model, logistic regression (binary, multinomial, ordinal, and conditional), survival analysis, model diagnosis, multiple imputation of longitudinal data, propensity score analysis (IPW, stratification, matching), sample size calculation, PRO instrument assessment and validation
- Good understanding of COA/PRO measures and instruments
- Act as technical consultant to other staff within EMC COA and Evidera.
- Recommends internal process improvements to good programming practices SOPs and other processes.
- Supervises/mentors junior staff.
- Willing to adjust and be flexible on working hours in order to stay communicated with the US COA team, as needed.
- Participates effectively on client calls and addresses questions related to the development and implementation of the SAP.
- Presents to internal teams and suggests alternative approaches towards analyses, documentation, and general process improvements.
Education, Professional Skills & Experience:
- Education fields: Epidemiology, Health Economics, Biostatistics or related field
- PhD with at least 1 year of relevant work experience, a Master's degree with at least 3 years of relevant work experience, or Bachelor’s degree with at least 5 years of relevant experience.
- Good understanding of epidemiology, biostatistics, and ICH guidelines.
- Computer programming or software skills required: Advanced knowledge of SAS Base, SAS macro, Microsoft Excel, Word, and PowerPoint.
- Good command of English
Personal Skills & Competencies:
- Inquisitive, curious, passionate about data, attention to minute details.
- 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.
- Presents ideas to individuals and groups in a formal presentation setting.
- Analyzes, responds to, and resolves enquiries, issues and escalations.
- Evaluates, plans and accomplishes multiple work goals in a timely fashion.
- Ability to quickly learn and apply new information, skills and procedures.
- 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.