Senior Programmer (Clinical Study)

CSL•Waltham, MA

About The Position

This role collaborates with study statisticians to design data structures and specifications for various deliverables, including ADaM datasets, Tables, Figures, Listings, and Analysis Submission content. The Senior Programmer leads the production and validation of these outputs, potentially overseeing work by CROs. They ensure the quality and accuracy of clinical data for submission readiness according to regulatory standards (SDTM, ADaM, tables, figures, listings, define.xml). The position also involves supporting the review of CRO-provided deliverables, leading efforts for pooled and exploratory analyses, and designing/implementing complex SAS programs for clinical trial data analysis in CDISC ADaM format. Additionally, the role focuses on identifying problems, developing global tools to enhance the Statistical Programming group's efficiency, and working closely with clinical study teams to meet project timelines with high-quality deliverables. Additional tasks include supporting CR&D staff in data analysis requests, performing integrated summaries of safety and efficacy, supporting publications and presentations, and replicating CRO/CSL statistician analyses for quality control.

Requirements

BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
At least 5 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
Understanding of clinical programming and/or statistical programming processes and standards.
Experiences with statistical programming using the SAS software including development and use of SAS Macros.
Knowledge in CDISC standards (CDASH, SDTM, ADaM).
Ability to work effectively in a team setting, and to meet set goals by managing own timelines.
Ability to work in cross-functional, multicultural and international clinical trial teams.
Good communication and analytical skills.
Good planning and organizational skills.
Ability to work successfully in a matrix organizational structure.
Networking skills and ability to share knowledge and experience amongst colleagues.
Fluent in English, oral and in writing.

Nice To Haves

Other degrees and certifications considered if commensurate with related programming experience

Responsibilities

Collaborates with the study statistician to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content.
Leads the production and validation efforts for the designed output, this may include oversight of work by CROs.
Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
Supports the review of related deliverables when provided by CROs.
Leads requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data.
Leads the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
Works closely with clinical study teams to ensure that project timelines are met with high quality deliverables.
Supports CR&D staff in data analysis requests.
Performs additional statistical analyses including but not limited to: Support responses to regulatory agencies, Generate integrated summary of safety and efficacy, Support publications and presentations, Support planning and reporting of clinical trials via exploratory analyses of available data, Replicate CRO and CSL statistician analyses for QC.