Associate Director, Statistical Programming

Kardigan•Princeton, NJ

7d•$181,000 - $250,000•Onsite

About The Position

The Associate Director of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks. This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this AD will play an important role in helping establish SOPs and programming standards and also build our SCE platform.

Requirements

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.

Nice To Haves

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

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.