Principal Biostatistician Job Description Template
Our company is looking for a Principal Biostatistician to join our team.
- Generates sample size calculations appropriate for the primary endpoint based on the protocol;
- Provide guidance for tables, listings and figures programming specifications as needed;
- Determines appropriate analysis for clinical endpoints based on the protocol and clinical team;
- Develops and reviews statistical analysis plans;
- Generates and reviews randomization schedules per protocol and randomization schema;
- Provides support to Data Safety Monitoring Boards by preparing and presenting the appropriate output;
- Provides advanced input into the statistical sections and overall consistency of the clinical study report;
- Communicates competently and independently with the clinical team to coordinate statistical and programming activities of the project;
- Performs the preparation, execution, reporting and documentation of high-quality statistical analysis according to the statistical analysis plan;
- Responsible for statistical considerations in FDA submissions;
- Assists in the development of project timelines, Standard Operating Procedures and guidance documents;
- Prepares and reviews statistical methods and results sections for the clinical study report with the medical writers and clinical team.
- Masters-level degree in Statistics, Biostatistics or related field with eight years relevant CRO industry or biotech experience; or;
- Doctorate-level degree in Statistics, Biostatistics or related field with six years relevant CRO industry or biotech experience;
- Knowledge with ICH, GCP, and regulatory guidelines;
- The ideal candidate will possess an advanced scientific degree MS in statistics or equivalent or PhD in statistics or equivalent;
- Strong knowledge and experience in SAS (SAS STAT, SAS BASE, SAS MACROS, SAS/ODS and SAS GRAPH);
- Working knowledge of SDTM/ADaM;
- 5 or more years of statistical analysis experience in the pharmaceutical or biotechnology industry or at a CRO preferably in oncology;
- Education or education/experience combination equivalent to a post graduate degree in statistics or statistics related field;
- Strong knowledge of study design and statistical analysis methods (e.g. survival analysis techniques, summary descriptive statistics);
- Solid knowledge in global regulatory guidance documents and requirements.