The Biostatistician is responsible for the statistical analysis and interpretation of clinical trial data, working closely with cross-functional teams to ensure accurate and meaningful results. This role involves developing Statistical Analysis Plans (SAPs)and contributing to the randomization process. They will provide expert consultation on statistical methodologies and collaborate with the Statistical Programming team to ensure the integrity of data analyses and outputs.
Responsibilities:
· Provide statistical expertise in the design and analysis of clinical trials.
· Develop and author SAPs for assigned projects.
· Review clinical trial protocols to ensure statistical soundness and provide feedback to study teams.
· Author the protocol statistical sections and generate SAPs and study randomization.
· Analyze clinical trial data using advanced statistical techniques and software.
· Collaborate closely with Statistical Programmers to review and validate data sets, tables, listings, and other statistical outputs.
· Review and sign-off on relevant study documents and data management and programming deliverables.
· Provide programming support to supplemental or exploratory analyses any other internal and external ad-hoc requests.
· Stay current with relevant regulatory guidelines and ensure compliance in all statistical deliverables.
· Represent the biostatistics function on project teams and in cross-functional meetings.
· Perform other duties as required and assigned.
Accountabilities:
· Demonstrate efficient and accurate completion of all responsibilities.
· Support overall delivery strategy and OKRs as directed by management.
Qualifications:
Education:
· Master’s or PhD in Statistics, Biostatistics, or a related field is required.
· Bachelor’s degree with substantial working experience in biostatistics will be considered.
Experience:
· 2+ years of biostatistics experience, preferably in clinical trials.
· Proficiency in statistical software such as SAS, R, or Python required.
· Experience in the life sciences, regulatory environments, and knowledge of 21 CFR Part 11 and GxP is highly preferred.
Skills:
· Strong statistical knowledge, including experience with survival analysis, mixed models, and longitudinal data analysis.
· Excellent problem-solving abilities and attention to detail.
· Demonstrated ability to work independently and within cross-functional teams.
· Strong written and verbal communication skills, with the ability to clearly present statistical findings.
· Familiarity with regulatory requirements for clinical trial data.
