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Kardigan · 1 day ago

Associate Director, Statistical Programming

Princeton, NJ

Full-time

Onsite

Lead/Staff, Director/Executive

$181K/yr - $250K/yr

8+ years exp

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The Associate Director of Statistical Programming will lead statistical programming activities, ensuring quality deliverables and collaboration between Biostatistics and Clinical Data Management.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

H1B Sponsor Likely

Responsibilities

Provides programming leadership and Oversee compound-level programming deliverable in collaboration with the Stats lead and cross-functional teams

Serve as the lead programmer to reviews SAP, Data Presentation Plan, Table Shell to align with project objectives and ensures clarity and completeness of programming assumptions and requirements

Lead programming team to produce and/or validate SDTM, ADaM and TLF, for CSR and regulatory requests, publication needs, and ad-hoc analyses

Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence

Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications

Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports

Develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming team

Develops robust program to create define.xml, Leads the NDA eSubmission package preparation

Assist Biometric in building the statistical computing environment (SCE) platform, including designing folder structure and managing access control

Under guidance from Head of Statistical Programming, implement innovative strategies and technologies to enhance programming processes

Working with manager, establish Statistical Programming standard and deploy programming strategies, specifications and programmed analysis

Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability

This position may manage direct reports as the programming team grows

In this role, AD is responsible for managing employees: set objectives, manage assignments and performance, and provide meaningful coaching and feedback

Support the evaluation and recruitment of potential employees

Manages junior programmers and internal contractors; provides mentorship

Qualification

SAS programmingSDTM implementationADaM programmingBiostatistics knowledgeCDISC standardsStatistical programmingCommunication skillsProblem-solving skillsCollaboration skillsAdaptability

Required

Master's degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field

Minimum of 8 years statistical programming experience in the pharmaceutical, biotech or CRO clinical trial environment

Advanced SAS programming skills. Extensive Hands-on experience with SDTM, ADaM, TLF programming

Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements

Good knowledge of drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology

Broad expertise in statistical programming and in developing computing strategies

In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials

Demonstrated proficiency in using SAS/R to produce analysis datasets and TFLs

Knowledge of data validation, define.xml generation using Pinnacle 21

Results orientated with proven problem-solving skills and a strong interest in ongoing learning

Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams

Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors

Adaptable and thrives in a fast-paced, startup environment while managing multiple priorities effectively

Preferred

Experience with regulatory audits and inspections and IR (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage

Company

Kardigan

Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.

Founded in 2023

South San Francisco, California, USA

51-200 employees

https://www.kardigan.bio

H1B Sponsorship

Kardigan has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (1)