Executive Director, Biostatistics

Duties and Responsibilities: The duties of a Biostatistician are to support clinical trials. Assure well-designed clinical trials. Provide statistical expertise necessary to support the design as well as analyze, interpret, and communicate the results of clinical trials. Perform duties of a Statistician to support regular clinical trials within national or international development projects as required. Collaborate with Trial Clinical Monitor and trial teams in planning clinical protocols conforming to company and regulatory agency guidelines. Support statistical Methodology sections for the protocols and the Statistical Analysis. Plans (SAPs) and author the TFL shells. Analyze data from phase I to III trials, including TFL shell development and responsibility for program validation. Review and evaluate proposed case report forms for consistency with information needs for the protocol. Review randomization to be used in the clinical trials.

Requirements and Qualifications: Ph. D. in Statistics, Biostatistics, Biometry, or a related quantitative field, with 5+ years of relevant experience. Demonstrated experience designing, conducting, analyzing, and/or presenting clinical trials or research studies, including applying statistical methodologies to research questions. Proficiency in SAS and/or R programming. Thorough knowledge of statistical methodology, clinical trial design, and clinical trial data processing and analysis. Strong written and verbal communication skills, with the ability to effectively collaborate across cross-functional teams. Strong attention to detail and commitment to quality, accuracy, and timely completion of deliverables.

Desired Skills and Experience: Clinical Biostatistics, Clinical Trial Design, Phase I-III Clinical Trials, Statistical Analysis, Statistical Methodology, Statistical Analysis Plans (SAPs), TFL Development, TFL Shells, SAS, R, Clinical Data Analysis, Statistical Programming, Program Validation, Protocol Development, CRF Review, Randomization, Clinical Trial Data Processing, Data Interpretation, Clinical Research, Regulatory Guidelines, Cross-Functional Collaboration, Statistical Reporting, Quality Control, Data Accuracy, Scientific Communication, PhD Statistics/Biostatistics, 5+ Years Relevant Experience Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.