Job Title: Biostatistician
FLSA Status: Exempt
Job Number: 07501008
Department: Pharmaceutical Sciences
Description:
Biostatistician with 1-3 years of experience supporting phase I through IV clinical trials and serving as lead biostatistician on clinical studies. Maintain the statistical integrity of clinical trials. Actively participate 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 may support meetings with drug regulatory agencies as required.
Essential Duties and Responsibilities:
- Participate in the planning and reporting of clinical trials. This includes addressing study design, sample size, CRF design and proposed methods of analysis, and associated liaisons with other clinical/operations staff;
- Maintain productivity and adherence to project target dates with respect to clinical development plans, clinical analysis plans, protocol development, analysis and report preparation for assigned projects;
- Peer review of project related work performed by other statisticians;
- Maintain compliance with latest Biostatistical regulatory requirements;
- Assist with the development and execution of validated SAS programs to list and summarize clinical trial data;
- Responsible for the statistical analysis and interpretation of data, and presentation of results in co-authored CSRs;
- Maintain study and project documentation and files according to departmental policy;
- Maintain external academic, professional and industry contacts.
Job Requirements:
Education: A Masters Degree preferably with a Biostatistics, Statistics, or Mathematics/Applied Mathematics major. A Doctorate Degree is preferred.
Experience: With a Masters Degree, at least 3 years of relevant work experience - clinical trial statistical work within pharmaceuticals, biopharmaceuticals, medical devices, CRO, or consulting. With a PhD, at least 1 year of relevant work experience - clinical trial statistical work within pharmaceuticals, biopharmaceuticals, medical devices, CRO, or consulting. Independent statistical project work experience and/or consulting with medical, clinical and programmers are desirable. Prior experience preparing regulatory submissions (e.g., NDA) is highly desired.
Specific Skills:
- Expertise with statistical software packages, e.g., SAS;
- Basic knowledge of regulatory guidelines;
- Strong communication skills, verbal and written.
Supervisory Responsibilities: None
Physical Demands/Work Environment: This position will require approximately 80% of time spent in an office environment sitting at a computer. Activities comprising the remaining 20% (meetings, conferences, co-worker interactions) will require moving between offices and buildings on the Arena campus and some travel.
