Manager/Senior Manager, Statistical Programming

Oruka Therapeutics

. Lead statistical programming activities for multiple clinical trials within a program or complete development program .

Posted 9/21/2026full-timeWaltham • Massachusetts • United StatesSenior💰 $146,000 - $187,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced SAS programming skills, including Macro language and BASE SAS, while ensuring compliance with FDA regulations and industry standards such as CDISC. Proven ability to lead statistical programming activities for clinical trials, manage CRO relationships, and produce high-quality statistical analysis deliverables.

Highest-signal resume keywords

Advanced SAS Programming SkillsLeadership in Statistical ProgrammingCDISC Standards KnowledgeClinical Trials Methodology ExpertiseRegulatory Compliance Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS ProgrammingMacro LanguageBASE SASSAS/STATSAS/GRAPHStatistical AnalysisProgramming SpecificationsValidation/QCR ProgrammingStatistical Programming Deliverables

Soft Skills

LeadershipCollaborationOrganizational SkillsInterpersonal SkillsAbility to Work Under Pressure

Tools & Technologies

CDISCECTDDefine.xmlTFL ShellsSDTMADaM

Industry Keywords

Clinical TrialsGood Clinical Practice (GCP)FDA RegulationsEMA GuidelinesICH GuidelinesNDA Submission

About the role

Key responsibilities & impact

Lead statistical programming activities for multiple clinical trials within a program or complete development program
Ensure timely, high-quality, compliant development and validation of statistical programming deliverables
Maintain audit readiness and accuracy of statistical analysis results
Produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publications, and ad-hoc analyses
Write specifications for programming requirements
Oversee CRO SAS programming and review activities, progress, quality, and timelines
Collaborate with Data Management, Biostatistics, clinical development, and cross-functional teams
Develop and review TFL shells, SDTM, and ADaM specifications
Identify issues and develop global tools, macros, or graphical user interface applications
Maintain advanced knowledge of SAS and industry requirements including CDISC, eCTD, and Define.xml
Represent statistical programming in audits, inspections, and Health Authority meetings
Provide technical recommendations and thought leadership
Adhere to FDA regulations, company SOPs/WIs, and department guidelines

Requirements

What you’ll need

BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 5+ years in a programming or statistical role
At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs, including coordination of large teams of internal and/or external programmers
Demonstrated leadership, collaboration, and organizational skills
In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
Advanced knowledge of CDISC standards and standard programs
Advanced SAS programming skills, including Macro language, BASE SAS, SAS/STAT, SAS/GRAPH, validation/QC, and generating listings, tables, and figures
Experience with R programming is a plus
Ability to program defensively, check results, and consistently produce accurate outputs
Knowledge of FDA, EMA, and ICH regulatory guidelines and submission requirements
Experience reviewing statistical analysis plans and developing technical programming specifications
Experience outsourcing programming activities and overseeing CROs and contractors
NDA submission experience is a plus
Excellent interpersonal skills and ability to operate effectively in a global environment
Ability to manage multiple responsibilities concurrently and meet deadlines under pressure

Benefits

Comp & perks

Competitive salary and benefits package
Equity
Performance-related bonus opportunity
Vibrant startup culture where work can directly impact bringing new medicines to patients
Supportive and inclusive team environment
Opportunities for professional growth and development