Are you searching for a career with great purpose? We are looking for a Biostatistician II to communicate with study team members relating to data quality and interpretation of results. This is an opportunity to transform healthcare, if you are interested then please apply.
- Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
- Perform protocol development, sample size calculation, protocol and CRF review.
- Advise data management staff on database design, validation checks and critical data.
- Write statistical sections of integrated reports.
- Provide statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables.
- Fulfill the Lead role for single complex studies or groups of studies.
- Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for studies.
- Perform the review of costings and attend bid defence meetings.
- Manage customer relationships.
- Provide training and guidance to lower level and new staff.
Skills and Requirements
- Minimum Bachelor's Degree Biostatistics or related field and 2-3 years relevant experience
- Typically requires 2-3 years of prior relevant experience, or equivalent combination of education, training and experience.
- Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention and accuracy with details.
- In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
- Strong working knowledge of SAS computing package.
- Familiarity with other relevant statistical computing packages such as StatXact.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.