Associate Statistical Programming Director - FSP

IQVIA • Durham, NC

4d

About The Position

Woven into the fabric of the sponsor’s development team, the Associate Director Statistical Programming is responsible for providing leadership and hands-on support in the development and maintenance of statistical programming capabilities which is required to meet regulatory obligations. This individual, working closely with the study team will be responsible for production of submission ready data (SDTM and ADaM), tables, figures, listings and submission packages. This individual will provide expertise 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 collaborate with other departments (e.g., 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. Responsibilities will include line management of a small team to drive their development, efficiency, innovation and career progression.

Requirements

• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience; Master’s degree preferred. Other degrees and certifications considered if commensurate with related programming experience
• At least 10 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
• 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 or 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.
• Good understanding of clinical programming and/or statistical programming processes and standards.
• Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
• Expert with statistical programming using SAS software
• Advanced in development or usage of SAS Macros.
• Strong programming and problem-solving skills.
• Expert knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Excellent communication and analytical skills.
• Strong interpersonal skills and effective leadership.
• Strong strategic planning and organizational skills.
• Ability to work successfully in a matrix organizational structure.
• A solutions-oriented mindset.
• Excellent accuracy and attention to detail.
• Networking skills and ability to share knowledge and experience amongst colleagues.
• Fluent in English.

Nice To Haves

• Presentations of programming techniques at professional conferences is a plus.

Responsibilities

• 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).
• May supports the review of related deliverables when provided by CROs.
• 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.
• Works closely with clinical study teams to plan and execute activities to ensure project timelines are met with high quality deliverables.
• Leads and oversees efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with 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).
• Performs additional statistical analyses including but not limited to: 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 client statistician analyses for QC purposes
• May support innovation initiatives to improve the efficiency and quality of statistical programming.
• Provides leadership to a team of direct reports

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees