The Sr. Biostatistician will provide statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical section of protocols, writing and reviewing statistical analysis plans, developing table, listing and figures shells, providing input to clinical development plans, and developing SAS programs.
Key Duties and Responsibilities
As a Senior Biostatistician, you will work closely with colleagues (Medical, Clinical Scientists, Statistical Programming, Data Management, Clinical Operations, Project Management, Medical Writing, Safety and Regulatory) as well as external CRO partners to:
- Oversee CROs, vendors, and consultants for the statistical deliverables, while ensuring consistency of approach for all studies assigned to CROs; review their adherence to timelines, as well as quality and cost.
- Consult in the design and development of clinical trials to ensure compliance with regulatory requirements, sponsor and CRO SOPs and working practice documents.
- Review study and project related documents that require statistical input, including the protocol, CRF and database design, SAP, SPP (statistical programming plan), and 3rd party data transfer specifications.
- Provide sample size calculations and generate randomization schedules as applied.
- Provide input into development of case report forms (CRFs).
- Develop and/or review statistical analysis plans, including the development tables, listings and figures (TFLs) shells.
- Review/validate SDTM and ADaM, ensure that CDISC compliance.
- Generate analysis datasets and TFLs to support the analysis of study data using SAS.
- Provide statistical (programming) support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Prepare statistical sections of clinical study reports.
- Participate in standardization efforts.
- Maintain effective and efficient communication both within the Biostatistician and Statistical Programming group and with the other functional groups.
- Contribute to or develop Biostatistics and quality standards, SOPs and WPs.
- Solve problems proactively and determine when and how to escalate issues.
- Keep manager informed of progress and any issues that may impact process compliance, data integrity, reporting accuracy, long term efficiency, timelines, or quality.
- Perform other functions as necessary or assigned.
Desired Education, Experience, Skills
- MS or PhD degree in Statistics and a minimum of 5 years of relevant industry experience. PhD’s degree preferred.
- Experience with oncology clinical trials strongly preferred.
- Experience in BLA/NDA Submission and/or interactions with the regulatory requests is strongly preferred.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- Experience with SAS.
- Knowledge of industry standards, such as the FDA guidelines, ICH guidelines and CDISC data structures.Experience with working with CRO’s, vendors, or consultants preferred.
- Must have demonstrated ability to support multiple difficult assignments with challenging timelines.
- Must have excellent verbal and written communication skills.
- The qualified applicant must be flexible, well-organized, and can work well under pressure and prioritize.
Location: San Diego or San Mateo, California
Min. Experience: Senior Level