Katalyst CRO ยท 4 weeks ago
Lead Statistical Programmer
San Francisco, CA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expKatalyst CRO is seeking a Lead Statistical Programmer to manage statistical programming activities across multiple clinical trials. The role involves overseeing external partners, ensuring compliance and quality in deliverables, and providing technical leadership in statistical programming.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead statistical programming activities and deliverables (e.g., SDTM/ADaM datasets, tables, listings, figures, review esub data packages with Pinnacle 21) across multiple studies and programs, serving as the primary programming point of contact. Must be able to review TMF for programming deliverables, including SAP
Oversee CRO programming activities by reviewing programming plans, SDTM/ADaM specifications, TLF shells, validation strategies, and issue logs
Monitor internal and CRO delivery against timelines, quality metrics, and contractual obligations; identify risks and implement mitigation or corrective actions as needed
Ensure consistency of standards, templates, macros, and processes across internal and external teams, and drive adoption of programming best practices
Provide hands-on programming support to complex or high-priority analyses, ad-hoc requests, and regulatory responses, as needed
Partner with biostatistics to design, implement, and maintain programming development plans for each project, ensuring timely and high-quality deliverables aligned with internal and industry standards
Partner with data management to apply CDISC standards during CRF design and database development
Partner with biostatistics, data management, clinical, regulatory, pharmacovigilance, and project management to align programming strategies with study-level plans and regulatory expectations
Collaborate with medical writing, clinical, and regulatory on study-level initiatives
Support inspection and audit readiness by ensuring appropriate documentation, traceability, and reproducibility of programming deliverables from both internal and CRO teams
Qualification
Required
Master's degree (or equivalent experience) in statistics, computer science, mathematics, or a related field
10+ years of programming experience in the pharmaceutical, biotechnology, or CRO industry
3-5 years of experience as a lead programmer in statistical programming and CRO oversight
Proven record in developing and implementing statistical programming standards and procedures
In-depth knowledge of CDISC (CDASH, SDTM, ADaM) standards and regulatory submission requirements
Advance proficiency in Base SAS, SAS/STAT, SAS Macro language, and SAS SQL; SAS/GRAPH a plus (SAS version 9 or higher)
Proficient in coding, debugging, and optimizing new and existing programs
Experience leading studies and supporting NDA and EMEA submissions
Adaptable, detail-oriented, effective under pressure with initiative to take on new challenges
Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction
Excellent analytical, problem-solving, organizational, and multitasking abilities
Excellent communication and interpersonal skills, both verbal and written
Collaborative team player with a customer-focused mindset; strives to support others to succeed
Ability to communicate technical information to non-scientists, and willingness to educate the internal team
Committed to quality and maintaining a positive attitude under shifting priorities
Ability to contribute to strategic planning for data standards, system infrastructure, and process optimization initiatives
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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