Associate Director, Statistical Programming (w/m/d)

Position Overview

The role provides leadership and expertise in developing and maintaining statistical programming capabilities critical for meeting regulatory obligations. Collaboration with senior directors and statisticians is vital to ensure accuracy and adherence to company standards in all statistical programming deliverables.

Main Responsibilities

• Assess upcoming activities with directors to determine resource needs, ensuring high-quality and timely delivery of projects.
• Oversee the delivery of clinical trial data sets and outputs, whether through external CROs or in-house programming.
• Plan and lead the design and implementation of complex programming specifications for analyzing clinical trial data.
• Coordinate oversight of exploratory analyses and respond to regulatory requests as needed.
• Mentor junior programmers and provide feedback to management regarding their performance.
• Ensure compliance with programming processes to facilitate accurate project execution.
• Implement innovative programming methods and drive the automation of processes, including the integration of AI.

Qualifications

A Bachelor's degree in Computer Science, Mathematics, Statistics, or a related field is required. Relevant experience may be considered for other degrees or certifications.

Experience

• Minimum of 9 years in clinical or statistical programming within a CRO or pharmaceutical environment, using SAS Software.
• Comprehensive understanding of clinical programming processes and standards.
• Advanced experience with SAS programming, including the development of SAS macros.
• Knowledge of CDISC standards (CDASH, SDTM, ADaM) is essential.
• Ability to work effectively both independently and in a team, managing timelines to achieve goals.
• Experience in cross-functional and multicultural clinical trial teams.

Core Competencies

• Expertise in coding with SAS and utilizing SAS macro language.
• Interest in expanding programming skills beyond SAS.
• Passion for automating routine programming tasks.
• Strong knowledge of clinical development processes.
• Excellent interpersonal and communication skills in English, particularly with senior management.
• Ability to thrive in a matrixed environment with a solutions-oriented mindset.
• Fluency in technical requirements for CDISC-compatible datasets.
• Experience presenting programming techniques at professional conferences is advantageous.

About CSL Vifor

We are committed to being a global leader in pharmaceuticals focused on iron deficiency and nephrology. Our mission encompasses forming strategic partnerships, developing cutting-edge therapies, and delivering them to improve patient health worldwide. CSL Vifor is headquartered in St. Gallen, Switzerland, with the parent company, CSL, based in Melbourne, Australia, overseeing a diverse workforce delivering innovative solutions globally.

Our Commitment to Inclusion

At CSL, inclusion and belonging drive our innovation. Through celebrating diversity and fostering an empathetic culture, we enhance our ability to connect with patients, stakeholders, and each other. We are dedicated to sustaining a diverse workforce that propels our mission forward.

Equal Opportunity Statement

CSL is an equal opportunity employer. We are committed to creating an accessible environment for all applicants.