Study Lead Statistician - Product Facing Location: Remote Duration: 12 months with possible extension Description: Ideal Candidate: Highly analytical, must have R and /OR SAS software experience as a biostatistician but not a programmer, has both statistical and clinical trial experience with life cycle drug development (pre-clinical Development, Clinical Development, and Post-marketing). The Study Lead Statistician (SLS) for product facing work is responsible for leading statistical activities of clinical studies and should be able to work independently with minimal guidance The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and Client standards, and maintain statistical, as well as operational, integrity throughout the life of the study. The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also works closely with the Study Statistician, who performs all the operational activities related to the statistics-related deliverables. The SLS should provide supervision and guidance to the Study Statistician. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include Regulatory activities, exploratory analyses, as well as publication/literature review and QCing publication work. Core Responsibilities: Provide statistical guidance, review, and contribution to protocols, SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications? Attend and be a contributor at Clinical Study Team Meetings Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review? Initiate cross-functional team meetings as necessary (e.g., SAP review, TFL shell review, TFL review) Provide statistical guidance, review, and be responsible for statistical analysis of individual studies/projects Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically) Perform data-driven modeling during clinical studies Coordinate the creation of required outputs for Dose Level Review Meetings (DLRMs) as well as coordinate and participate in the DLRM Review TFLs created by statistical programming for consistency and accuracy Author analysis reports such as Flash Memo, and results section of the CSRs Collaborate with the study programming team for study deliverables Manage timelines for all statistics-related deliverables by working with the cross-functional team members (e.g., programmers, study statisticians, clinical data managers, medical writers) Be familiar with all Company’s policies, SOPs and other controlled documents related to study activities noted above Assist with study and systems audits conducted by Company GCA and external bodies Minimum Education Required: Master's degree in Statistics/Biostatistics or other subject with high statistical content with at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research (or PhD degree with at least 3 years' experience) Strong skill in communicating statistical information clearly and concisely (written and oral) Strong understanding of statistical concepts related to the design and conduct of clinical studies Strong ability to apply statistical methodologies in the analysis of clinical trials Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia Previous experience in the development, author, and execution of protocols and SAPs, as well as review of CSRs Excellent oral and written English communication skills. Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study designs Preferred Qualifications: Master's degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research Designing, analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia Demonstrated ability in presenting results and defending statistical findings, study design and analysis to internal audiences (study/product team) AND at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing) Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS Demonstrated ability to influence decision making Experience in adaptive clinical trials and innovative study designs Experience in the utilization of Bayesian statistics in clinical trials Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs Top 3 Must Have Skill Sets: Prefer the candidates with R programming skills in addition to SAS programming skills. Simulation work and developing R-shiny app may be needed. Proactive and positive work attitude. Good communication and collaboration skills are a plus. Day to Day Responsibilities: Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, analysis, and medical publications. Executing statistical and exploratory analyses to publications, study planning, and regulatory responses in a timely manner. Performing QC analyses and exploratory analysis of studies/projects and developing conclusions and recommendations. Analyze and explore the clinical trial data for study planning, adhoc requests, publications, and regulatory RTQs Red Flags: Lack of analytical skills Lack of experience and knowledge for clinical trial and clinical trial data Experience as the SAS programmer and no experience as a biostatistician Inability to speak to experience in resume Passive work attitude without asking questions and turn in work without statistical sense As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.