Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Senior Biostatistician II to join our A-team (hybrid*). The Sr. Biostatistician II (Sr2Bios) supports the statistical analysis and clinical data activities of the Allucent Biostatistics/Statistical Programming team. This position leads projects, writes statistical documents and statistical sections of study documents for simple to moderately complex studies, and provides senior review of statistical documents and outputs. This position may assist in the programming of datasets and outputs using SAS®. The Sr2Bios will regularly interact with other members of the Allucent biostatistics project team and will interact with clients when leading a study.
In this role your key tasks will include:
- Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial data
- Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderately complex studies
- Familiarity with complex statistical methods and concepts
- Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity
- Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
- Interpret and communicate results for complex statistical analyses and outputs
- Develop and/or review the statistical sections of a study protocol for simple to moderately complex studies
- Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses
- Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications
- Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports
- Support responses to regulatory questions on statistical issues relating to client regulatory submissions
- Working knowledge of SAS® for production and validation of datasets and statistical outputs
- Write and review specifications for complex ADaM or analysis datasets
- Annotate or review annotations of TLF mocks to assist programming efforts.
- Working knowledge of CDISC standards
- Review CRF design to ensure it conforms with the study protocol and analysis needs.
- Knowledge in clinical research with emphasis in the development and support of the analysis of clinical trial dat
- Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for simple to moderately complex studies.
- Familiarity with complex statistical methods and concepts
- Provide senior reviews of statistical documents, data, and outputs for simple to moderately complex studies to ensure quality and integrity
- Execute a statistical analysis of any complexity as specified in a protocol or analysis plan
- Interpret and communicate results for complex statistical analyses and outputs
- Develop and/or review the statistical sections of a study protocol for simple to moderately complex studies
- Review data management documents as requested to ensure the integrity of study data
- Lead simple to moderately complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing
- Lead management of project budgets, the identification of out-of-scope work, and the change order process
- Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings
- Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value.
- Actively support staff learning & development within the company
- Identify, recommend, and execute departmental initiatives, tools, and process solutions to enhance efficiency and quality.
- Review and evaluate biostatistics and statistical programming processes and procedures within the Quality Management System
- Represent Allucent at proposal bid defences and/or marketing meetings with prospective clients
- Establish positive relationships with current and future clients.
