Epoch Technology & Consultation Services (ETCS) - Chennai, Tamil Nadu GENERAL SUMMARY: Plays a functional lead role

in the design, analysis, and reporting of clinical studies. Writes statistical analysis plans, performs statistical analyses, contr ibutes to and reviews study reports, and interacts with other study team members and clients on study set up and conduct, including timelines and financial over sight. ACCOUNTABILITIES: 1. Develops statistical analysis plans and reporting specifications for simple c linical studies. a. Develops and describes appropriate statistical techniques for the analysis of data in a statistical analysis plan. b. Takes direction from other statisticians on statistical methodology, study de sign, therapeutic area details, and data analysis. c. Works closely with analysis programmers and medical writers to design appropr iate shells and specifications for outputs that can be produced efficiently. d. In lead role on studies, reviews statistical analysis plan if written by othe rs. 2. Performs statistical analyses and interprets results from simple clinical stu dies. a. Develops or QCs analysis programs to implement techniques described in the st atistical analysis plan. b. Approves final database for freeze/lock. c. Assesses model assumptions for statistical analyses d. Works with programmers, writers, and clinicians to coordinate data summarizat ion and analysis activities, including summary statistics, tabulations, graphics , analysis output, and raw data listings. e. Reviews statistical reports and statistical sections of clinical study report s. 3. Contributes statistical expertise to project teams for the design, analysis, and reporting of simple clinical studies. a. Serves as primary functional representative on project teams. b. Participates in the development and review of CRFs, data edit specifications, and critical variable lists c. Works with the project manager and functional manager to determine resource p rojections and project schedules. d. Visits clients to discuss statistical issues. 4. Maintains and develops knowledge of company and industry procedures and metho dologies. a. Performs billable work in accordance with PRA s policies, procedures, and SOPs. b. Maintains basic knowledge of drug development process. c. Maintains basic knowledge of SAS procedures and good programming practices. d. Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses. e. Develops awareness of FDA and EMEA guidelines and requirements for reporting of clinical trial data MINIMUM QUALIFICATIONS: MS degree in Statistics or Biostatistics Awareness of multiple statistical and therapeutic areas Ability to plan, implement, and monitor the statistical processes for a clinical study Good communication skills with leadership potential Total Number of Openings: 2

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