Senior Biostatistician, Clinical Trial Experience Required

reputed company: • Assist with development and modification of department SOPs and work instructions • Train new Biostatistics employees and mentor junior Biostatisticians • reputed company study bids and reputed company changes for prospective reputed company RFPs • Present Biostatistics study execution tasks at capabilities presentations • Serve as reputed company statistical contact for reputed company project team members • Manage Biostatistics tasks reputed company project timelines and communicate reputed company changes • Identify and communicate changes in reputed company • Review case report forms and completion instructions • reputed company input on database design and data-edit considerations • reputed company or review Interim Analysis Plans and Statistical Analysis Plans • reputed company or review SDTM and ADaM dataset specifications and mock tables, listings, and figures • Independently program derived datasets and TLFs and validate corresponding programs • Review programming by other team members • reputed company or review statistical reputed company and results sections for reports, CSRs, and publications • Plan and design clinical studies, including endpoints, power analysis, randomization, blinding, and protocol statistical reputed company • reputed company or review Randomization Plans and randomization programs or lists • reputed company activities according to CTI SOPs, project conventions, GCP, and ICH guidelines • Maintain accurate work records and file statistics documents in the eTMF • Participate in departmental meetings Requirements: • At least 4 years of reputed company biostatistics experience in a pharmaceutical, CRO, or reputed company statistical environment • Master’s degree in Biostatistics, Statistics, or a reputed company field • CDISC, SDTM, and ADaM dataset mapping experience • BLA/NDA submission experience preferred • Regulatory representation experience preferred, including meeting preparation/attendance and regulatory communication follow-up • Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology, and rare disease preferred • Experience providing statistical consulting to internal/reputed company clients preferred • Ability to work reputed company Good Clinical reputed company and International Conference on Harmonization guidelines • Knowledge of biostatistics SOPs and project-specific conventions • Ability to independently program derived datasets and TLFs and validate programs • Experience with Interim Analysis Plans, Statistical Analysis Plans, Randomization Plans, SDTM, ADaM, and clinical study reports Benefits: • reputed company mentoring program • Leadership courses • Tuition reimbursement • Ongoing education and training • Dedicated training department • Award-reputed company company culture • Work-life balance support • Generous health benefits • Vacation packages • Hybrid work from home opportunities • reputed company parental leave • CTI Cares program • Career progression support Apply To This Job