Supports lead biostatistician on clinical studies; may serve as lead biostatistician with oversight from a more senior biostatistician. Maintains the statistical integrity of clinical trials analyzed by SDC. Assists in preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, and writing statistical sections of clinical study reports.
- Assist in writing statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
- Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol
- Assist in developing SDTM and ADaM mapping documents and datasets
- Program summary tables, data listings and graphical representations of clinical trials data
- Assist in performing analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
- Perform statistical QC of final clinical study reports
- Contribute to the development of standard operating procedures for clinical trials
- Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
- Adhere to all aspects of the SDC’s quality system
- Comply with SDC’s data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
- Strong analytical skills, with the ability to process scientific and medical data
- Able to work independently
- Excellent knowledge of statistical programming
- Proficient in manipulating and analyzing SAS data
- Ability to identify data issues, present problems, and implement solutions.
- Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
- Good organizational and time management skills, with the ability to multi-task
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Strong interpersonal communication and presentation skills
Education or Equivalent Experience:
Master’s or doctorate degree in biostatistics, statistics or other related, scientific field an 1-3 years of relevant professional experience; or an equivalent combination of relevant education and/or experience.