Statistician/Junior Statistician

Junior Statistician / StatisticianJob title: Junior Statistician / StatisticianBusiness: Clinical ServicesReports to: Senior VP Clinical ServicesLocation: Remote - WFH (United States)Full-timeCompensation: $60K-$100K, annual salary compensation based on experience.Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.Position Summary:We are seeking a detail-oriented and analytical Junior Statistician/Statistician (title based on education & experience) to join our Clinical Data team. In this role, you will assist in analyzing clinical trial data, generating statistical summaries, and ensuring compliance with regulatory standards. You will work closely with senior biostatisticians and clinical data managers to support the statistical design, implementation, and analysis of clinical studies. This is a position ideal for someone with 3-5 years of experience looking to grow and expand their career in statistical analysis and data science.Duties:Implementation and execution of methodological and statistical aspects of clinical studies. Manage biostatistical activities related to drug product development for assigned clinical studies. Collaborate with study teams internally and with clients, manage study timelines, and ensure quality of statistical analysis output.Qualifications:Bachelor’s (4-5 years of experience) OR Masters (3-4 years of experience) degree in Statistics, Mathematics, Biostatistics, Data Science, or a related quantitative field. Master’s degree preferred.Excellent communication skills & good programming skills in SAS, S-plus or other statistical software, and ability to work in a team environment.Knowledge of concepts and methodologies of QA and relevant regulatory requirements.Specific Responsibilities:• Perform descriptive and inferential analysis of Clinical data and provide statistical assistance in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents.• Write, validate and work on biostatistical programs for development of a Statistical Analysis Plan, statistical analysis and derived analysis datasets.• Ensure the accuracy and quality of the statistical analysis output.• Manage study resources and timelines.• Have in-depth knowledge of FDA and ICH guidelines and regulations and industry data standards, e.g., CDISC, SDTM and ADaM.• Develop, revise and/or review SOPs relating to biostatistical services.• May provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.Salary: $60K-$100KBenefits:401k Employer Match with immediate vestingVision Insurance Medical and Dental Insurance with multiple coverage optionsFSA (Medical, Dependent Care, and Commuter)Short Term DisabilityLong Term Disability Life InsuranceGenerous Paid Holidays and PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.