ORGANIZATION: Acelity DEPARTMENT: Global Clinical Affairs REPORTS TO: Senior Manager, Biostatistics
STATUS: Full Time JOB CODE: Biostatistics Technical II UPDATED: 17 September 2018
Job Summary: The Biostatistician will work closely with the supervising statistician and Biostatistics team to support project needs. This individual will have knowledge in applied parametric and nonparametric statistics and strong SAS programming skills. S/he will support on stages of the clinical trial work from study design, study endpoints, statistical methods, protocol development, SAP development, specification writing, data review, and CSR completion. This individual will work closely with the Biostatistics team and supervising Statistician. S/he ensures statistical analyses are conducted with the highest level of clinical ethics, scientific integrity and data
Principal Responsibilities: (essential job duties and responsibilities)
- Provides statistical support for clinical studies (Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR))
- 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
- Work with programmers to provide tables, listings and graphs, including ad hoc validation
- 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.
- Establishes, maintains, and ensures compliance with Standard Operating Procedures, Quality Procedures, and Work Instructions.
- Maintain knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Perform activities and tasks as directed by supervisor
- Bachelors or Master’s Degree in Statistics, Biostatistics or related field with experience in Clinical Research setting. Minimum 2-4 yrs. for BS, 0-2 yrs. for MS.
- Knowledge in applied parametric and nonparametric statistics and strong SAS programming skills.
- Demonstrated organizational skills with the ability to prioritize workload
- Must possess strong interpersonal and communication skills, effectively communicating both verbally and in written format.
- Strong attention to detai
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor