Senior Executive, Statistical Programming

The Senior Executive will support one or more Phase I-IV studies programming activities as per the project strategies. The incumbent should be able to work in a team environment implementing and executing the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with PTL, internal partnering functions and external functional service providers to ensure all the programming deliverables are delivered in timely manner with high quality.

 

In this role, a typical day might include the following:

• Support statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables in assigned projects and areas.

• Update and maintain programming documentations following programming standards and processes. Update CDISC standard SDTM mapping specifications and ADaM specifications.

• Develop and validate SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).

• Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.

• Participate in the CRF annotation, TLFs specifications development and macros development.

• Contribute to all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for the regulatory submission to FDA/EMA/PMDA or other agencies.

• Support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.

• Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.

• Prioritize and manage the assignments and responsibilities on a need basis in a timely manner.

• Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.

• Performing end-to-end programming activities and act as a team player.

 

This Role May Be For You If Have

• Strong SAS programming skills in a clinical data environment with excellent analytical skills. Some knowledge of other programming languages such as R, Python etc. is a plus.

• Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).

• Good working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Attention to detail, quick learner and able to adapt to a fast-paced environment.

• Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset.

• Problem solving and innovative skills that demonstrate initiative and motivation.

• Demonstrated and applied SAS programming skills. SAS certificates a plus.

 

To Be Considered For This Opportunity You Must Have

• with