Essential Duties and Responsibilities:
- Provides statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data).
- Collaborate with investigators to identify problems and provide statistical consultation including design of experiments or surveys, analysis of data, interpretation of results and preparation of reports.
- Provide support to other Biostatisticians or Statistical Programmers creating ADaM datasets as well as tables, figures, and listings.
- Generate, document, and maintain clinical datasets and reports.
- Assist with client data organization and management.
- Perform statistical computations.
- Prepare and maintain data analytical files.
- Communicate technical information to non-statisticians.
- Maintain project related responsibility.
- Maintain a consistent work schedule in accordance with departmental and company expectations.
- Provides input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations).
Required Qualifications:
- Master’s degree in Biostatistics or Statistics field.
- Some SAS experience preferred.
- Familiarity with general linear models, survival analysis, and categorical data analysis.
- Knowledge of CDISC standards in the development of SDTM and ADaM datasets will be a plus.
Knowledge, Skills and Abilities
- Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods.
- Strong verbal and written communication skills.
- Ability to communicate programming issues with non-technical staff.
- Exceptional attention to detail.
- Ability to work on multiple tasks under tight timelines.