The Senior Biostatistician serves as the sponsor lead biostatistician on clinical studies and may serve a similar role on NDAs/BLAs with some level of oversight by the supervisor. As the lead, the individual contributes to study design, protocol development, case report form development, clinical study reports, and exhibits for other reports and presentations. The individual is responsible for sample size and power calculations, randomizations, statistical analysis plans, analysis datasets, data displays such as tables/figures/listings, statistical programming, and analysis and interpretation of results. The individual ensures that the analysis plans use the most appropriate statistical methods; ensures that the data displays are accurate and complete; programs or independently validates key study results; and conducts statistical analysis of study data to generate results and insights used to support study findings. If the statistics work is partly or wholly outsourced to a CRO, the sponsor lead biostatistician has overall accountability and responsibility for the CRO’s statistical tasks and outputs and serves as the approver for the outputs.
Writes specifications for derived datasets and data analysis
Reviews and organizes study data
Ensures compliance of data packages to regulatory requirements and CDISC and industry standards
Compiles, analyzes, and reports statistical results for various projects
Carries out moderately complex statistical analyses with minimal supervision according to a statistical analysis plan
Applies advanced statistical methods, which may include simulation models and other statistical programming as needed
Contributes to the development and maintenance of standard macros and programs used in creating datasets and data displays
Assesses relevant literature as well as existing data, evaluates the quality of data used in reports and assists with preparation and distribution of periodic reports
Prepares written reports and summarizes data for investigators with minimal supervision
Based on level of experience, makes original contributions to research projects and takes initiative in professional activities
Provide statistical representation at regulatory or other external meetings
Provide statistical programming support to clinical studies or regulatory submissions
Works closely with Data Management by providing input to data management-related documents and assisting with data review and cleaning activities as needed.
Closely collaborates and participates in knowledge sharing with other team members
Interfaces with non-statisticians to assist with interpretation and understanding of results.
Participates in special projects to improve processes, tools, systems, and organization
MS/MPH or PhD/DrPH degree in Biostatistics, Statistics, or Epidemiology
4-7 years (if MS/MPH) or 1-4 years (if PhD/DrPH) of clinical trial experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry
Strong experience in Phases I-III of the clinical drug development process; experience working on NDAs/BLAs preferred
Solid statistical skills, including broad knowledge and clear understanding of statistical concepts and techniques commonly applied to the analysis of data from clinical trials and demonstrated ability to tackle from moderately complex to complex statistical or data issues.
Highly proficient in SAS programming, with solid hands-on experience using SAS/BASE, SAS MACROS, SAS/STAT, SAS/GRAPH, and SAS ODS
Experience with other statistical computing software, such as R, is preferred
Strong working knowledge of CDISC standards
Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS)
Strong working knowledge of EDC systems
Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving
Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job.
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.