Senior Manager, Statistical Programming: Autoimmune Lead

Vor Biopharma; Boston (MA); In loco; USD 190.000 - 205.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health coverage

Flexible PTO

Parental leave

401(k)

Descrizione del lavoro

Vor Biopharma is seeking a Senior Manager, Statistical Programming to lead and deliver high-quality programming for complex clinical studies. You will drive SDTM/ADaM data development, ensure regulatory-ready outputs, and mentor junior programmers while partnering with Biostatistics, Data Management, and Clinical Operations.

The role requires 7+ years in pharmaceutical statistical programming, strong SAS skills, and CDISC expertise, with the ability to manage multiple studies and deliver on

Competenze

• Master's degree in Statistics, Mathematics, Computer Science, or a related discipline.
• Minimum of 7 years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment.
• Strong hands-on SAS programming skills and experience with clinical trial reporting.
• Strong knowledge of CDISC standards, including SDTM, ADaM, metadata, controlled terminology, data flow, and FDA electronic submission requirements.
• Experience independently developing and validating analysis datasets, programming specifications, and TFLs.
• Demonstrated experience serving as a lead programmer for Phase 2 or Phase 3 clinical studies, with the ability to independently manage study-level programming deliverables.
• Good understanding of clinical development, medical data, and common safety and efficacy domains.
• Strong analytical, problem-solving, debugging, and quality-control skills.
• Ability to manage multiple study deliverables, adapt to changing priorities, and work effectively with cross-functional teams.
• Strong written and verbal communication skills.
• Experience in autoimmune disease, neurology, or rare-disease clinical development is preferred.
• Working knowledge of R or other programming technologies is desirable.

Mansioni

• Lead study programmer and review analysis plans and development of mock TFLs.
• Develop, validate SDTM and ADaM datasets, programming specifications, metadata, and support documentation.
• Program and validate tables, figures, and listings for efficacy, safety, pharmacokinetic, pharmacodynamic, and clinical outcomes.
• Design and develop SAS programs, macros, and reusable utilities (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and ODS).
• Transform and integrate data from EDC systems, IRT systems, laboratories, eCOA platforms, and other sources.
• Perform quality control reviews of SAS programs, datasets, specifications, logs, and outputs.
• Support regulatory submissions through prepare/validate SDTM, ADaM, define.xml, SDRG, ADRG, annotated CRFs.
• Review and resolve CDISC submission findings.
• Maintain clear traceability from source data through SDTM, ADaM, and final statistical outputs.
• Contribute to programming standards, templates, automation, and process improvements.
• Provide technical guidance and peer review to less experienced programmers.

Conoscenze

SAS programming

CDISC standards

lead programmer

analytical skills

communication skills

cross-functional

problem solving

Formazione

Master's degree in Statistics

Strumenti

Base SAS

SAS Macro

SAS/STAT

SAS/GRAPH

ODS

R

Descrizione del lavoro

Vor Biopharma is seeking a Senior Manager, Statistical Programming to lead and deliver high-quality programming for complex clinical studies. You will drive SDTM/ADaM data development, ensure regulatory-ready outputs, and mentor junior programmers while partnering with Biostatistics, Data Management, and Clinical Operations.

The role requires 7+ years in pharmaceutical statistical programming, strong SAS skills, and CDISC expertise, with the ability to manage multiple studies and deliver on