A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Statistical Programmer
Job Description
The Senior Statistical Programmer is responsible for all statistical programming aspects of 1-2 studies or assigned project-level activities. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans in Pharma are executed efficiently with timely and high quality deliverables.
1. Lead statistical programming activities as Trial Programmer for 1-2 studies or assigned project-level activities. If assigned to cross-project aligned group (e.g. Standards), manage at least one, macro/utility function or local project. 2.Co-ordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the study/studies. Make statistical programming recommendations at study level.
3.Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team.
4.Review eCRF, discuss data structures and review activities as member of the Data Review Team.
5.Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans. 6.Provide input into statistical programming solutions and/or ensure their efficient implementation.
7.Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications
8.If assigned to cross-project aligned group (e.g. Standards), be responsible for an end-to-end development of a macro or utility function, or at least one local project under supervision.
9.Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. 10.Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.
Candidate Profile
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written). Relavant Experience in Statistical Programmer
Additional Information:
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Quality
Job ID: 234034BR
Last Date: 15th March, 2018
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