Position Title: Senior Manager, Statistical Programming
Department: Clinical Data Sciences & Analytics
Reports To: Head of Statistical Programming
Location: South San Francisco, CA or Princeton, NJ - On-site 4 days per week (Mon to Thurs)
Job Overview:The Senior Manager 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 position will play an important role in helping establish SOPs and programming standards and also build our SCE platform.
ESSENTIAL DUTIES AND RESPONSIBILITIESKey Project 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.
Initiative Responsibilities:- Under guidance from Head of Statistical Programming and Compound PL, 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.
Qualifications and Preferred SkillsEducation:- Master's degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field.
Experience and Skill Set:- 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.
- Experience with regulatory audits and inspections and IR (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.
Exact Compensation may vary based on skills, experience and location.
Pay range
$172,000-$234,000 USD
