Biostatistician Stat4ward, LLC provides statistical consulting services to pharmaceutical companies, medical device companies, diagnostic companies, as well as other fields that use general statistics. Our highly-trained statisticians are experts in pharmaceutical and IVD/LDT industries, with focus on data analysis, study design, and statistical analysis plans. We also support and guide critical decision-making, publications, submissions, and interaction with regulatory agencies. To learn more about us please view our website: https://stat4ward.com/ We are currently looking for two (2) Biostatisticians. The duties and responsibilities are as follows: 1. Assume the responsibilities of Biostatistician and leadership for Biostatistics activities at the project level. 2. Provide strategic, statistical, and scientific input to ensure analyses meet project goals, scientific and regulatory requirements. 3. Manage multiple concurrent projects and participate in internal and client-facing meetings as needed. 4. Perform statistical and programming tasks related to project deliverables, collaborating closely with cross-functional teams. 5. Draft statistical sections of the protocols, statistical analysis plans (SAPs), statistical reports including clinical study reports (CSRs) and manuscripts; develop randomization schemes. 6. Interpret and summarize study and statistical analysis results for internal and external stakeholders. 7. Develop and/or review shell documents for tables, figures and listings (TFLs) and delivery of final outputs. 8. Provide statistical review and programming support for ad hoc exploratory analyses requested by project team, programs and validate outputs as appropriate. 9. Determine/define and apply appropriate statistical methodologies to support study objectives. 10. Stay current with emerging statistical analysis methods and techniques in line with FDA guidance. 11. Ensure consistency in the use of validated tools, training materials and compliance with standard processes, policies, and procedures. 12. Perform additional duties as assigned to meet company needs and Sponsor milestones. Minimum Requirements: 1. Master's Degree in Biostatistics, Business Analytics, or Applied Statistics. 2. Must have completed at least 4 semester-long graduate-level courses in applied statistics, probability, data science, machine learning, and mathematical statistics. Minimum 2 courses in writing and speaking. Please send all applications to serena.sin@stat4ward.com