Senior Manager, Statistical Programming
About The Position
Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments for cardiovascular diseases. Led by experienced co-founders who previously led MyoKardia, Kardigan possesses a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team focused on improving patient lives. Kardigan is driven by values such as patient focus, authenticity, eagerness to learn, teamwork, and enabling the impossible, all aimed at making a significant difference in patients' lives. The Senior Manager of Statistical Programming will lead statistical programming activities, including hands-on implementation of statistical analyses using SAS/R, and quality reviews of deliverables for both in-house and outsourced programming tasks. This role acts as a crucial link between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. The position will also contribute to establishing SOPs, programming standards, and building the SCE platform.
Requirements
- Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.
- Minimum of 6 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 study to 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.
- Implement innovative strategies and technologies to enhance programming processes.
- 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.
Benefits
- Exact Compensation may vary based on skills, experience and location.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
