Novartis is a global healthcare leader and has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We appreciate and welcome your interest in joining our team of associates from more than 150 nationalities who currently share our mission to care and to cure. Our career website is updated regularly and can be viewed in other languages by selecting the option in the upper right corner.

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.
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Minimum Requirements –

  • BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written).

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