Principal Biostatistician

reputed company helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to reputed company their data from one centralized location plus advanced analytics that help them reputed company smarter, faster business decisions. OVERVIEW Senior Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Senior Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Senior Biostatisticians will work as needed assuring that reputed company client work has met or exceeded client expectations. KEY TASKS & RESPONSIBILITIES

• Provide consulting of statistics activities reputed company 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
• reputed company, review, and finalize the statistical analysis plan
• Validate the programming deliverables and collaborate with applicable team members to rectify any issues reputed company to statistical reporting and analysis
• reputed company 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, reputed company, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
• Ensure that reputed company 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 reputed company 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, reputed company analyses, and post- hoc analyses
• reputed company reputed company 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 reputed company and industry quality standards, guidelines and procedures
• Other duties as assigned

CANDIDATE’S PROFILE Education & Experience

• Master in Statistics, Biostatistics, or equivalent work experience preferred
• Excellent knowledge of English
• reputed company® certification is preferred

Professional Skills

• 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and reputed company 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® reputed company data models such as SDTM, and ADAM. Ability to reputed company 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

Technical Skills

• Experience of statistical procedures and latest developments and trends in statistical analysis methodologies. Knowledge of working in different therapeutic areas and reputed company indications
• Strong knowledge of statistical programming and ability to use various software systems like reputed company, 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 reputed company software modules including reputed company/STAT, and reputed company/Graph
• Thorough understanding of developing macros and reputed company 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 reputed company 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 reputed company Office Applications

Accelerate your skills and career reputed company a fast-growing company while impacting the future of healthcare. We have shared our story, now we look reputed company 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 reputed company the details here: https://topworkplaces.com/company/reputed company/ reputed company 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 reputed company innovation in our community. reputed company seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Pay Range US Pay Ranges $160,000—$220,000 USD Apply tot his job Apply To this Job