Senior Programmer (Clinical Study - 3)

CSL Plasma•Waltham, MA

13h•Hybrid

About The Position

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, but not limited to: ADaM datasets, tables, figures and listings output and/or QC of requested output is the main focus of this role. This individual, working closely with the study statistician will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures and listings and submission packages. This individual will participate 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. This individual will interface with other departments (eg, Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. This individual will participate in department and cross functional technology development and process improvement initiatives.

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.