Provide expert statistical, process and regulatory knowledge to the department. Perform project management function within the Biostatistics department. Oversee the statistical aspects of clinical trials from design, through analysis and reporting, acting as thelead statistician on multiple projects.
Represent the Biostatistics department within the company and with interactions with client companies and regulatory agencies.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
- Expert knowledge of the statistical principles underlying clinical trials.
- Expert statistical skills.
- Expert knowledge of the regulatory issues associated with the reporting of clinical data in the submission process.
- Expert consultative skills.
- SAS® programming skills and familiarity of other statistical packages (e.g. StatXact, Nquery) and understanding of database structures.
- Good organizational skills across multiple projects, managing own and team work loads.
- The ability to adapt and adjust to changing priorities.
- Excellent written and verbal communication skills.
- Ability to work in a multi-disciplinary team setting.
- Demonstrated initiative, motivation and problem solving skills.
- Positive attitude and the ability to organise a team and work well with others.
- Evidence of mentoring skills as shown by leadership of multiple projects and team members.
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.