eClinical Solutions - Principal Biostatistician

• Master in Statistics, Biostatistics, or equivalent work experience preferred • Excellent knowledge of English • SAS® certification is preferred • 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred • Strong experience with clinical study design development, analysis, and sample size determination • Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule • Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA • Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses • Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes • Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures • Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time • Ability to balance conflicting priorities • Excellent verbal and written communication skills • Detail oriented, ability to multitask with strong prioritization, planning and organization skills • Excellent team player • Experience of statistical procedures and latest developments and trends in statistical analysis methodologies. Knowledge of working in different therapeutic areas and related indications • Strong knowledge of statistical programming and ability to use various software systems like SAS, SPSS, and S-Plus. Ability to do statistical computing using R is a plus • Knowledge and ability to use various tools like J-Review, and Spotfire for effective data queries and analysis • Strong experience in various SAS software modules including SAS/STAT, and SAS/Graph • Thorough understanding of developing macros and SAS system • Thorough knowledge of design of experiments and statistical modeling. Experience of developing statistical designs for phase-I, phase-II, and phase-III clinical protocols • Experience of pooled data analysis and in designing specifications for integrating data from multiple trials • Knowledge of Analysis dataset model for development of analysis and programming specifications is a plus. Ability to develop ADAM models based on trial data • Thorough knowledge of analysis of various standard and non-standard safety domains. Knowledge of PK data modeling is a plus • Strong experience in efficacy reporting with regards to development of analysis sets, and treating missing values • Proficiency in Microsoft Office Applications • Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! • eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/ • eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!