eClinical Solutions 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 all their data from one centralized location plus advanced analytics that help them make 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 the development of the 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 the development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Senior Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations. 

KEY TASKS & RESPONSIBILITIES

• Provide consulting on statistical activities related to clinical trials. Fulfill the responsibilities of study statistician as required
• Generates sample size calculations appropriate for the primary endpoint based on the protocol
• 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 clients and with the clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get the correct specifications and data at the 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 schedules, specifications, and guidelines
• Wherever applicable, provide input in the 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 concerning statistical reports 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

CANDIDATE’S PROFILE

Education & Experience

• Master in Statistics, Biostatistics, or equivalent work experience preferred
• Excellent knowledge of English
• SAS® certification is a plus

Professional Skills

• 5+ years in the Pharmaceutical/Biotechnology industry or equivalent statistical consulting
• Strong experience with clinical study design development, analysis, and sample size determination
• Experience with the development of randomization schedules including the 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 the FDA, and EMEA
• Experience in developing statistical analysis 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, MedDRA) and clinical reporting processes
• Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM specifications.
• 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 with statistical procedures and the latest developments and trends in statistical analysis methodologies. Knowledge of working in different therapeutic areas and related indications. Experience in oncology is a plus
• Strong knowledge of statistical programming and ability to use various software systems like SAS, SPSS, and S-Plus. The 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 in pooled data analysis and in designing specifications for integrating data from multiple trials
• Knowledge of the Analysis dataset model for the 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 regard 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!

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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.