CORE JOB TASK 1) Provide statistical input the clinical development of drugs. 2) Assist in developing the technical details of client proposed documents. 3) Participate in clinical study design protocol development as the role of project statistician. 4) Ensures that project-related biostatistics programming work is carried out in a timely compliant manner. 5) Establishes maintains effective working relationships with study teams, including data management personnel, statistical programmers, clinical research regulatory personnel corporate partners. 6) Develop review Statistical Analysis Plan (SAP) TLF mock shells fclinical studies. 7) Conduct statistical analysis CSR validation. 8) Conduct statistical programming validation. 9) Review critical statistical documents analysis deliverables 10) Develop review statistical reports development fclinical studies. 11) Participate in review randomization schedule development. 12) Provide statistical support fIDMC other disciplines related to biostatistics. 13) Provide input in the preparation of scientific presentations manuscripts. 14) Act as statistical consultant to clients study team in related disciplines. 15) Carry out all activities according to SOPs working within the framework of the Quality management System to Good Clinical Practice (GCP) 16) Train mentjunibiostatisticians. 17) Perform other duties as requested by management. 18) Participate in process improvement, training, standards development enhancing statistical technical expertise. 19) Interviewing selection of potential candidates 20) Provide ongoing training mentoring within Statistical analyst junistatistician to ensure thorough knowledge of the processes used ongoing technical development. 21) Manage the statistician resource provide necessary support to project team 22) Support business development activities. MINIMUM REQUIREMENTS 1) PhD in Statistics related field with 3+ years’ experience 2) Master’s degree in Statistics related field with5+ years’ experience in pharmaceutical industry 3) Good sense about statistical model 4) Excellent verbal written communication skills, including formal presentation skills 5) Excellent analytical skills 6) Fluent in written spoken English, CET6 is preferred 7) Hands on SAS skills in Base SAS, basic Macro programming SAS/STAT. 8) Experience in development of SAS code R code
