Senior Manager 1

The Senior Manager 1 will provide comprehensive programming and people management expertise to lead and support all programming activities as per the project strategies. The incumbent should be able to work independently 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 internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in timely manner with high quality. The incumbent will participate in and contribute to department goals, SOPs, macros, SME topics and act as a technical expertise to provide guidelines on CDISC standards.

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

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.
In a positive/collaborative environment, manage and mentor new hires and junior programmers.

This Role May Be For You If You Have

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

To Be Considered For This Opportunity You Must Have

Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 12+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.

Senior Manager 1, Statistical Programming

Regulatory Affairs Manager/Senior Manager-(EP)