Seeking a skilled Biostatistician to contribute to our team in the analysis and interpretation of statistical data. This role plays a crucial part in ensuring accurate reporting of results from clinical study data.
Key Responsibilities
* Provide expert advice on study design.
* Collaborate with cross-functional teams to develop study protocols.
* Develop, review and implement statistical plans and randomization schedules.
* Prepare listings, tables and figures for clinical study reports.
* Perform and review complex statistical analyses.
* Internal review of statistical methodology and results sections of clinical study reports.
* Liaise with Data Management teams regarding data transfer and review of Case Report Forms and Data Management Plans.
* Assist with pharmacokinetic analyses as needed.
* Coordinate with bioanalytical laboratories about data transfer.
* Support preparation and review of clinical study reports.
* Participate in client meetings and communication.
Required Qualifications, Skills and Experience
* Higher degree in relevant field (highly desirable).
* Minimum 2-3 years experience in statistical analysis in pharmaceutical or health research.
* Working knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.
* SAS programming skills (highly desirable).
* Understanding of pharmacokinetics (highly desirable).
* Excellent written and verbal communication skills including report preparation and coordination.
* Strong organisational skills with ability to prioritise tasks, solve problems and coordinate multiple projects.
* Proven ability to deliver high-quality results under pressure in a team environment.
* Demonstrated initiative, trustworthiness and reliability with autonomy to work unsupervised.
* Intermediate to advanced MS Word and Excel proficiency.
Benefits and Opportunities
A reputable growing CRO offering stability, diversity and inclusivity, strong emphasis on collaboration, training and career development opportunities and attractive remuneration package.