Director, Statistical Programming

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: 

The Director, Biostatistics and Statistical Programming provides input regarding planning, management and logistics for biostatistics and statistical programming services. The Director, Biostatistics and Statistical Programming assists in developing the strategic vision for all biostatistics and statistical programming activities. The Director, Biostatistics and Statistical Programming 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. The Director, Biostatistics and Statistical Programming will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements.

KEY TASKS & RESPONSIBILITIES

• Provide input regarding planning, management and logistics for biostatistics and statistical programming services.
• Determine resourcing needs per project load, deadline requirements and resource utilization
• Assist in developing the strategic vision of the department which can be integrated into the overall corporate vision. 
• Support the development of policies, procedures and standards. 
• Participate in resource management and allocation activities.
• 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 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 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. 

Education & Experience 

• Bachelor’s or Master’s degree or equivalent work experience preferred 
• 15+ years’ experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred 
• Excellent knowledge of English 
• SAS® certification is preferred

Professional Skills & Experience

• 15+ 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

Technical Skills

• 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.

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