Principal Biostatistician - Thebarton, Australia - Avance Clinical
Description
AVANCE CLINICAL
Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.
Broad Purpose
The Principal Biostatistician is responsible for performing statistical design, analysis and reporting of clinical studies, and also mentoring of Avance staff in these activities.
Reporting Relationships
Reports to Statistics Team Manager / Senior Biostatistician
Core Responsibilities
- Provide statistical advice on study design.
- Provide statistical input in the development of study protocols.
- Prepare/review randomisation schedules.
- Prepare/review statistical analysis plans.
- Prepare/review listings, tables and figures of study data.
- Perform/review statistical analyses of study data.
- Prepare/review efficacy sections of clinical study reports.
- Client liaison for statistics or study design related issues.
- Participate in client meetings.
- Mentor role for statistics team members, and also for staff in the Clinical and Data teams, for development of statistics skills.
- Provide Business Development support for proposals including statistical presentation/analysis.
- Other duties as directed by Line Management or delegate.
Departmental Responsibilities
- Maintain effective communication with other members of the statistics team, and study team members of other disciplines.
Organisational Responsibilities
- Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike.
- Commitment to Avance Clinical training programs.
- Commitment to adhere to Avance quality systems.
Qualifications, Skills and Experience
- Bachelor's degree or higher with an emphasis in life sciences, medical/pharmaceutical sciences and/or statistics.
- Minimum of 10 years statistical analysis experience.
- Minimum 10 years' experience in the pharmaceutical industry / Contract Research Organisation (CRO) working in a GCP environment.
- Minimum of 3 years' experience in tertiary education and/or equivalent mentoring
- Formal GCP training and experience with regulatory filing of statistics.
- Experience in clinical or pharmacological research with a focus in a technical writing environment.
- Proven experience with SAS together with advanced skills in MS Word and MS Excel.
- Ability to communicate with clients, senior management and other stakeholders.
- Excellent oral and written communications skills including the ability to prepare reports and procedures.
- Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
- Ability to work under pressure in a multidisciplinary team environment.
- Commercial links with pharmaceutical and biotechnology industry _(desirable)._
Other
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands as above.
- Likewise, qualifications listed are representative of the knowledge, skills and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Salary:
$90, $130,000.00 per year
Benefits:
- Travel reimbursement
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Thebarton, SA 5031: Reliably commute or planning to relocate before starting work (required)
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