Senior Statistical Programmer - FSP

Job Detail

Main Responsibilities and Accountabilities:

Collaborates with the study teams to design data structures and specifications for ad hoc and study deliverables, including but not limited to ADaM datasets, Tables, Figures, listings, and Analysis Submission content.
Collaborates with study teams 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).
Leads and oversees requested efforts for pooled and exploratory analyses working closely with the Statistics TA lead and/or study statisticians as well as with the clinical programming team and their collection of legacy data.
Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures, and listings) when not provided by the CRO.
Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
Works closely with clinical study teams to plan and execute activities to ensure project timelines are met with high-quality deliverables.

Additional tasks:

Collaborates with CR&D staff regarding 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,

Position Qualifications and Experience Requirements:

Education

BSc in Computer Science, Mathematics, Statistics, or related area with relevant experience

Experience

At least 5+ years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment
In-depth understanding of clinical programming and/or statistical programming processes and standards.
Extensive experience with statistical programming using SAS software, including development and use of SAS Macros. Strong programming and problem-solving skills.
Good experience in R Programming is mandatory for this role (hands-on experience)
Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.
Experience in working in cross-functional, multicultural and international clinical trial teams.

Apply for the job Application ends in 5d 38min

OR apply with

An easy way to apply for this job. Use the following social media.