Premier global, high growth San Antonio Company is adding to the team due to growth. This well- established Company is known for its phenomenal benefits, single-digit turnover, team atmosphere, internal promotion track record, and work-life balance. It has an incredible reputation for being people-centric and a huge contributor to the community.

The Senior Biostatistician will have knowledge of clinical trials and will advise on all stages of the clinical trial work from study design, study endpoints, statistical methods, protocol development, SAP development, specification writing, data review, and CSR completion. S/he ensures statistical analyses are conducted with the highest level of clinical ethics, scientific integrity, and data quality.

This Global Clinical Affairs Biostatistics team member is a highly motivated, eager, humble, positive, solutions-oriented individual. This is a great collaborative, and transparent group.

The Senior Biostatistician serves a lead role on projects. He/she interacts with team members in designing and analyzing clinical trials. Key responsibilities and skills include but are not limited to: Responsible for protocol development including study design, sample size estimation, randomization, and statistical analysis plan for assigned studies

Responsibilities: 

• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
• Responsible for validity of analysis and alternative analysis strategies 
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings
• Applies programming expertise in SAS® and other analytical software (i.e. nQuery) to clinical trial applications and other non-trial research data.
• Performs statistical analyses of clinical and non-clinical data as necessary for management decisions, regulatory requests for information, commercial support, pre-clinical and publication support.
• Stays current with statistical methodology in clinical trial design and analysis.
• Works collaboratively with other departments/teams (e.g., Safety, Data Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Research and Development) on statistical items.
• Provides input to the study team and offers solutions to project challenges.
• Maintain awareness of industry standards (such as ICH/GCP and ISO), regulatory requirements (such as CFR, ISO, and MDR), and departmental operating procedures.
• Participates in process improvement initiatives.

Minimum Qualifications:

• Master’s Degree in Statistics, Biostatistics or related field.
• Minimum 3-5 yrs. with experience in Clinical Research setting
• Knowledge in applied parametric and nonparametric statistics and strong SAS programming skills.
• Demonstrated organizational skills with the ability to prioritize workload 
• Builds strong relationships with peers and cross functionally with partners outside of team to enable better collaboration.
• Possesses a working understanding of clinical trial processes
• Provide oversight to programmers, and junior statisticians
• Knowledge of ICH-GCP and applicable regulatory requirements a plus

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Compensation: $110,000 - $120,000 Plus 15% bonus, several weeks of vacation, GREAT benefits !!!  Position included relocation or can be remote.