Serves as lead biostatistician on clinical studies. Maintains the statistical integrity of clinical trials analyzed by SDC. Actively participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.
- Act as the lead statistician on clinical research projects
- Provide statistical expertise for study design of clinical trial protocols
- Write statistical methods section of the study protocol, as needed
- Write 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
- Program summary tables, data listings and graphical representations of clinical trials data
- Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
- Prepare key sections of clinical study reports and various regulatory documents
- Perform statistical QC of final clinical study reports
- Provide statistical support to answer questions from external clients (such as FDA, Investigators)
- 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.
- Excellent analytical skills, with the ability to process scientific and medical data
- Able to work independently
- Excellent knowledge of statistical programming
- Expertise 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 leadership, 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
- Ability to effectively collaborate across cross-functional teams
Education or Equivalent Experience:
Master’s degree in biostatistics, statistics or other related, scientific field and five years of relevant professional experience; or an equivalent combination of relevant education and/or experience. A PhD in biostatistics, statistics, or other related, scientific field is preferred.