[Remote] Principal Biostatistician

Note: The job is a remote job and is open to candidates in USA. eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services. The Principal Biostatistician will provide high-level consulting services for statistical analysis and programming, ensuring that all client work meets or exceeds expectations while collaborating with various teams to support trial progression and regulatory reviews. Responsibilities • Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required • Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming • Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time • Develop, review, and finalize the statistical analysis plan • Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis • Develop randomization schedule, specifications, and guidelines • Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting • Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables • Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately • Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses • Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses • Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports • Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures • Other duties as assigned Skills • Excellent knowledge of English • 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 • Master in Statistics, Biostatistics, or equivalent work experience preferred • SAS® certification is preferred • 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred Company Overview • eClinical Solutions is a data intelligence hub.it transforms the way clinical data integration, aggregation, and analytics. It was founded in 2006, and is headquartered in Mansfield, Massachusetts, USA, with a workforce of 201-500 employees. Its website is http://www.eclinicalsol.com. Company H1B Sponsorship • eClinical Solutions has a track record of offering H1B sponsorships, with 10 in 2025, 7 in 2024, 8 in 2023, 5 in 2022, 5 in 2021. Please note that this does not guarantee sponsorship for this specific role.