Principal Statistical Programmer

Job Description Summary

Job Description

Major accountabilities:

• 1. Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development.

• 2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project 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 resource plan) e.g. as member of the extended Clinical Trial Team (CTT).

• 4. Review eCRF discuss data structures and participate in data review activities as member of the extended CTT.

• 5. Comply with company department and industry standards (e.g. CDISC) and processes assess and clarify additional programming requirements at project-level review and develop programming specifications as part of the analysis plans.

• 6. Provide and implement statistical programming solutions; ensure knowledge sharing.

• 7. In consultation with the Statistician responsible for development of programming specifications of analysis datasets and pooled datasets.

• 8. 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.

• 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 advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM eCTD ) attend functional meetings and trainings.

• 11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance

• 12. As assigned act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures.

Key Performance Indicators (Indicate how performance for this job will be measured) :

1. Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers including the Clinical Trial Team Lead/Program Statistician and the functional/operational manager.

2. Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members.

3. Ability and effectiveness in training mentoring and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager.

Job Dimensions (Indicate key facts and figures) Number of associates:

No direct reports. Coordination of 5 internal and external programmers. Financial responsibility: (Budget Cost Sales etc.) None Impact on the organization:

1. Timely high quality and efficiently produced statistical programming deliverables included in study and project level documents (incl. submissions)

2. Reliable and compliant statistical analysis results presented externally (incl. submissions)

3. Innovative technical solutions to support timely and efficient drug development deliverables Ideal Background (State the preferred education and experience level) Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics computer science mathematics life sciences or related field Languages: Fluent English (oral and written).

Experience/Professional requirement:

1. Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables

2. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications

3. Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs

4. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP study procedures).

5. Good communications and negotiation skills ability to work well with others globally

6. Experience as Trial Programmer including coordination of internal or external programmers on a given study/project

7. Ideally 5years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry

Skills Desired