An Acelity™ Global Clinical Affairs Biostatistics team member is a highly motivated, eager, humble, positive, solutions-oriented individual. The Senior Biostatistician provides input and support for department and project activities as an individual contributor. The Senior Biostatistician will have knowledge of clinical trials and will advise on all stages of the clinical trial work from study design, study endpoints, statistical methods, protocol development, SAP development, specification writing, data review, and CSR completion. S/he ensures statistical analyses are conducted with the highest level of clinical ethics, scientific integrity and data quality while meeting internal timelines.
Principal Responsibilities: (essential job duties and responsibilities)
- The Senior Biostatistician serves a lead role on projects. He/she interacts with team members in designing and analyzing clinical trials. Key responsibilities and skills include but are not limited to: Responsible for protocol development including study design, sample size estimation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise.
- Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
- Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings
- Applies programming expertise in SAS® and other analytical software (i.e. nQuery) to clinical trial applications and other non-trial research data.
- Performs statistical analyses of clinical and non-clinical data as necessary for management decisions, regulatory requests for information, commercial support, pre-clinical and publication support.
- Stays current with statistical methodology in clinical trial design and analysis.
- Engages in analyses to exploit information to improve product/study design and business/analysis decision-making
- Provide ad hoc data driven analyses
- Works collaboratively with the supervising statistician and other departments/teams (e.g., Safety, Data Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Research and Development) on statistical items.
- Accountable for ensuring that deliverables and timelines are met while providing high quality results.
- Works with manager to set challenging, achievable goals which contribute to department objectives.
- Actively participates in department and project team meetings and activities
- Provides input to the study team and offers solutions to project challenges.
- Maintain awareness of industry standards (such as ICH/GCP and ISO), regulatory requirements (such as CFR, ISO, and MDR), and departmental operating procedures.
- Participates in process improvement initiatives.
- Flexibility in shifting priorities according to company needs.
- Perform activities and tasks as directed by supervisor.
- Master’s Degree in Statistics, Biostatistics or related field.
- Minimum 3-5 yrs. with experience in Clinical Research setting
- Knowledge in applied parametric and nonparametric statistics and strong SAS programming skills.
- Demonstrated organizational skills with the ability to prioritize workload
- Strong attention to detail
- Must possess strong interpersonal and communication skills, effectively able to communicate both verbally and in written format.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable better collaboration.
- Willingness to go the extra mile to get results.
- Recognizes and acknowledges teammates contributions.
- Readily acknowledges and takes ownership of mistakes, offering and accepting apologies graciously.
- Self-directed and comfortable working in teams or independently and exercises sound judgement.
- Possesses a working understanding of clinical trial processes
- Provide oversight to programmers, and junior statisticians
- Knowledge of ICH-GCP and applicable regulatory requirements
- Possess attributes aligned with department culture including: Accountability, Respect, Trust, and Fun.