Responsibilities
The Senior Statistical Programmer is responsible for providing hands‑on support and technical guidance on clinical study teams. The development of study and ad‑hoc output, including ADaM datasets, tables, figures, and listings output and/or QC of requested output, is the main focus of this role. This individual works closely with the study statistician and is responsible for review and acceptance of contract research organization (CRO) deliverables, which are mainly datasets in submission‑ready standard format (ADaM), tables, figures, listings, and submission packages.
The role includes participation in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for all requested analyses. The individual interfaces with other departments (e.g., Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure SOPs are followed and the correct study data are used for all requests.
The Senior Statistical Programmer also participates in department and cross‑functional technology development and process improvement initiatives.
Main Responsibilities and Accountabilities
* Collaborates with the study statistician to design data structure and specifications for ad‑hoc and study deliverables.
* Leads the production and validation efforts for the designed output, including 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.
* Supports the review of related deliverables when provided by CROs.
* Leads requested efforts for pooled and exploratory analyses, working closely with the clinical programming team.
* Leads the in‑house specification and delivery of ISS and ISE datasets and associated output 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.
Additional Tasks
* Supports CR&D staff in data analysis requests.
* Performs additional statistical analyses, including support responses to regulatory agencies, generating integrated summary of safety and efficacy, supporting publications and presentations, and supporting planning and reporting of clinical trials via exploratory analyses of available data.
* Replicates CRO and CSL statistician analyses for QC.
Job Qualifications and Experience Requirements
Education
* BSc in Computer Science, Mathematics, Statistics or related area with relevant experience.
* Other degrees and certifications considered if commensurate with related programming experience.
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.
* Experience with statistical programming using SAS software, including development and use of SAS Macros.
* Knowledge of CDISC standards (CDASH, SDTM, ADaM).
* Ability to work effectively in a team setting and meet goals by managing own timelines.
* Ability to work in cross‑functional, multicultural, and international clinical trial teams.
Competencies
* 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.
Compensation
The expected base salary range for this position at hiring is $143,000 - $169,000 USD for the Waltham, MA USA location. Individual base salary is determined by qualifications, skill level, experience, competencies and other relevant factors.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit the accessibility statement.
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