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Job ID : 204654BR
Position Title : Associate Director SP
Division : Global Drug Development
Business Unit : GDO GDD
Work Location : Hyderabad
Functional Area : Research & Development
Job Description :
- The Associate Director Statistical Programming is responsible for all statistical programming aspects of one or more drug development projects. This is a key leader position ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables. It is a leader role with strong understanding of drug development process, experience in regulatory activities and key statistical reporting aspects with a track record of operational leadership..Lead statistical programming activities as a Lead/Program Programmer for a large-sized or complex project or group of projects globally or locally with phase I to IV clinical studies in Novartis Global Drug Development.
- 2. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at project level. Develop statistical programming strategy and scientific documentation for the project(s) together with the Biostatistician(s).
- 3. May act as functional manager local/global associates including providing supervision and advice to these programmers on functional expertise and processes.
- 4. May act as an operational manager also, being accountable for associates’ professional development/training, performance management. Build highly efficient team.
- 5. Build and maintain effective working relationship with cross-functional teams incl. Biostatistics and Data Management counterparts, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan). SP representative at project-level and in the Submission team, or in local leadership team.
- 6. Comply with company, department and industry standards (e.g. CDISC) and processes, ensuring statistical programming innovations and foster statistical programming solutions, ensure their efficient implementations and knowledge sharing within the project(s).
- 7. Accountable for timely and quality development and validation of all statistical programming components on assigned project(s). Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
- 8. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
- 9. Represent Statistical Programming at audits and in Health Authority (HA) meetings for assigned project(s), or on technical programming aspects in external conferences or groups (e.g. CDISC).
- 10. Provide authoritative technical and professional recommendations as representative of the statistical programming function at project level or for a major non-clinical initiative
- 11. Recruit talent, coach and develop statistical programmers.
Minimum Requirements –
- BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written).