The Senior Manager, Biostatistics provides project support for RWD/RWE analyses.
Responsibilities
Develops individual protocol/SAP and determines appropriate statistical methodology for RWD/RWE studies.
Analyzes large datasets from diverse sources, including claims databases, registries, patient-reported outcomes, and EHR.
Participates in database design meetings to ensure that the data collected are in high quality and satisfy analysis requirements.
Collaborates with the statistical programming staff to ensure that all programs meet analysis and external requirements.
Performs key and innovative part of the analyses and interprets results.
Prepares oral and written reports to effectively communicate results.
Reviews stat related documents during projects initiation, conduct and reporting when external vendors involved.
Is involved in research activities for innovative statistical methods and applications.
Prepares materials and conducts training to internal/external audience in venue initiated by MA and commercial.
Provides statistical consultation and review to other request from other functions (i.e. clinical development or commercial).
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Qualifications
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 2 years relevant work experience, or a Masterβs degree with a minimum of 4 years relevant work experience (see each box for detailed year requirement).
Basic knowledge of statistical analysis methodologies and experimental design.
Basic knowledge of relational databases and programming languages such as SQL, R, Python, or SAS in big data environment.
Demonstrates interest in statistical research activities and application of novel methods to clinical trial development and RWE.
Basic good presentation, oral and written communication skills.
Ability to learn, being proactive, motivated, and consistently focus on details and execution.
Ability to work in a team environment with cross-functional team members.
Computer Skills: SQL, R, Python, SAS, Microsoft office apps.
Skills
Statistical programming and data analysis
RWD/RWE study design and methodology
Database design and data quality assessment
Communication of complex statistical results
Education
PhD in statistics/biostatistics or related discipline or Masterβs degree with relevant experience as specified above.