13 Oct
covalent trainings
Secunderabad
Job Description
Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practices (WPs). Serve as a lead statistician on selected single projects. Ensure projects are well documented consistent with company SOPs and working practices. Time management of own and team's time spent on projects. Interact with the sponsor on statistical aspects of the project. Produce sample size calculations. Provide input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contribute to writing appropriate protocol sections. Provide randomization schemes and appropriate documentation,
on selected projects. Develop statistical analysis plans, including table, listing and graph specifications. Specify the general structure of the analysis database, provide programming support for its development and validation. Produce statistical analyses and statistical appendices, with appropriate documentation. Validate statistical analyses and statistical appendices, with appropriate documentation. Prepare Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required. Contribute statistical methods section for Integrated Clinical Statistical Reports. Review Integrated Clinical Statistical Reports. Qualification:- BA/BS or equivalent degree in computer science, statistics, biostatistics, mathematics or related field and at least 5 years of programming in clinical research or related experience OR relevant MA/MS or equivalent plus 3 years of programming in clinical research or related experience.
Must have SAS or equivalent statistical/BI software package programming experience; SDTM, Tables & Listing, Adams experience required Knowledge, Skills and Abilities:- Proficient in one or more programming languages. Ability to train and mentor others. Understanding of relational data base structure and experience working with complex data systems. Demonstrated strong attention to detail. Excellent problem solving and innovative skills. Good written and verbal communications skills. Ability to independently and effectively organize and manage multiple assignments with challenging timelines. Ability to adapt and adjust to changing priorities. I