Title: Manager 1, Statistical Programming

• Lead 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.

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

• Develop and oversee the development of 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 macros, participate in establishing and maintaining statistical programming standards.

• Participate in the CRF annotation, review of SAP, TLFs specifications development and TLFs review.

• Handle 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.

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

• Participate and contribute towards department goals, SOPs, training guidelines and SME topics.

• Mentor and Coach new hires and junior programmers.

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

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

• Great working knowledge of implementing CDISC standards, Regulatory guidance and TAUG.

• 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.

• Hands-on programming as well as people and process management experience.

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

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