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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
277288BR
Senior BiostatisticianJob Description
Responsible and accountable for the statistical activities and support on statistical solutions for trials/publications and conferences. Activities include providing input on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and explor-atory analyses. Responsible for transcribing analysis plans into computational solutions for the stats programmer to implement (specs of derived variables, specification and development of statistical computing solutions for inferential stat analyses, TFL templates for key reporting documents like the CSR) of Phase I-IV clinical trials. Ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, list-ings and figures for phase I-IV clinical trials and submission activities. Assume responsibility for reporting and analysis execution for multiple studies. Re-sponsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, and scien-tific analytical solutions. Lead study teams to ensure high quality for all assigned deliverables and processes and ensure audit-readiness. Responsible for ensuring statistical deliverables are provided to agreed timelines. Maintain and build effective relationships with internal and external customers, utiliz-ing support of management as needed. Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-stats, and provide adequate statistical justifications for actions/decisions/statements, when re-quired. Provide stat analysis solutions when exploratory analyses are required. Implement novel methods and innovative trial designs with support from lead stat and/or stat methodology as required. Develop and comply with project / study standards and specs following in-ternal guidelines. Support quality control and audit of deliverables. Provide input on process improvement initiatives and participate in non-clinical pro-ject activities with support from group head. Participate in non-clinical project activities as needed. Provide support, coaching and mentoring to more junior stats.
Minimum requirements
MS/ MSc (in Statistics or equivalent) with 5+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years of work experience Fluent English (oral and written) - Working knowledge of/experience with SAS/ R or any other business or research analytic software with an expertise in at least one type of software. - Statistical and numerical knowledge and expertise in analytic aspects. - Excellent interpersonal and communication skills. - Strong understanding of global clinical trial practices, procedures, methodologies. - Strong understanding of regulatory requirements for design, analysis and reporting of clinical trials.
,Keyskills :
processimprovementinitiatives qualitycontrol datastructures clinicaltrials processimprovement statisticalconcepts compatibilitytesting statisticalcomputing tatementsofw ksow regulat yrequirements clini