Lead Statistical Programmer

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Remote, Contract Lead Programmer – 12-months with potential to renew long-term

Job Summary:

The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas. The role oversees external CRO partners to ensure high-quality, timely, and compliant delivery of analysis datasets, tables, listings, and figures that support clinical development and regulatory submissions. The position involves hands-on technical leadership and requires comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and the drug development process.

Essential Duties and 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.

Minimum Education, Certifications, Licenses, and Experience:
 

• 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.

Additional Experience (Nice to Have):

• Ability to contribute to strategic planning for data standards, system infrastructure, and process optimization initiatives.

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