Manager, Statistical Programming at Lifelancer

We are seeking a dedicated and seasoned Manager, Statistical Programming to join our dynamic team at Lifelancer. The successful candidate will be responsible for directing, planning, and executing the work of the statistical programming team, providing critical project leadership, and supporting clinical studies through expert programming guidance.

Key Responsibilities

• Determine resourcing needs per project load, deadline requirements, and resource utilization.
• Create, review, and approve programming plans at both study and project levels.
• Provide input on key study-related documents produced by other functions (e.g., CRFs, Data Management Plans, SAPs).
• Develop and maintain programming and validation specifications for TLGs as outlined by the Biostatistician.
• Create and maintain SAS programs to support clinical trial analysis and reporting.
• Assist Biostatisticians with algorithm suggestions for novel analysis requests.
• Develop analysis datasets for trial-level reporting and integrated safety and efficacy activities.
• Program and QC data listings, summaries, and graphs as defined in SAP.
• Develop reusable utility macros to support programming tables, listings, and graphs across all clinical trial reporting phases.
• Create submission-ready SDTM and ADaM datasets following standard industry procedures.
• Perform peer review of all SAS Programmers' deliverables.
• Serve as a Subject Matter Expert for Statistical deliverables, leading task forces to develop complex, technical solutions.
• Collaborate with project teams and other Professional Services Managers to ensure timely, high-quality deliverables.
• Develop and maintain strong working relationships with internal cross-functional teams and clients.
• Develop, revise, and maintain Standard Operating Procedures and Work Instructions, and assist in their training.
• Maintain all project documentation in compliance with SOPs and Processes.
• Ensure adherence to Lifelancer and industry quality standards, guidelines, and procedures.
• May serve as Lead Statistical Programmer on projects as needed.
• Other duties as assigned.

Candidate Profile

Education and Experience

• Bachelor of Science or Master of Science in Statistics, health-related field, computer science, or equivalent.
• Minimum 10 years of experience in the Pharmaceutical/Biotechnology industry or an equivalent IT consulting role.

Professional Skills

• Strong experience in preparations for NDA filings.
• Excellent knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA).
• Familiarity with CDISC® related data models like SDTM and ADaM.
• Experience working on multiple clinical protocols simultaneously.
• Exceptional verbal and written communication skills.
• Detail-oriented with strong prioritization, planning, and organizational skills.
• Excellent team player.

Technical Skills

• Extensive experience in extracting, manipulating, merging, summarizing, analyzing, and presenting data using SAS procedures.
• Strong proficiency in base SAS programming, Proc SQL, macro programming, ODS, and various SAS modules such as SAS/GRAPH, SAS/STAT, SAS/Connect, and SAS/Access.
• Experience with reporting environments and tools related to SAS programming in the pharmaceutical industry (e.g., proc report, proc summary, proc tabulate).
• Strong background in SAS programming across different clinical trial phases.
• Experience in pooled data analysis and programming.
• Depth in efficacy reporting regarding the development of analysis sets and managing missing values.
• Experience working with relational databases and optimizing SAS programming performance.

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Company: Lifelancer
Job Title: Manager, Statistical Programming