• 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 in support of the lead 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.

• Support in the development and/or review of the statistical analysis plan

• Conduct the statistical review of 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, support the development and validation of the study specific list of table and table shells for clinical study reports and for study specific deliverables.

• 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

• Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures.

• Master’s degree in Statistics, Biostatistics, or related field

• 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role

• 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

• Familiarity with 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 and 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. Thorough understanding of SDTM data structures

• 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