Skills

Analysis Skillsunmatched

Best Practicesunmatched

Biostatisticsunmatched

Biotech and Pharmaceuticalunmatched

Case Report Form (CRF)unmatched

Clinical Dataunmatched

Clinical Data Interchange Standards Consortium (CDISC)unmatched

Clinical Practices/Protocolsunmatched

Clinical Supportunmatched

Clinical Trialunmatched

Code Reviewsunmatched

Communication Skillsunmatched

Computer Programmingunmatched

Computer Scienceunmatched

Contract Requirementsunmatched

Contract Research Organization (CRO)unmatched

Corrective Actionunmatched

Customer Relationsunmatched

Data Managementunmatched

Data Setsunmatched

Database Designunmatched

Database Programmingunmatched

Debugging Skillsunmatched

Detail Orientedunmatched

Documentationunmatched

Drug Developmentunmatched

Industry Standardsunmatched

Interpersonal Skillsunmatched

Leadershipunmatched

Mathematicsunmatched

Medical Writingunmatched

Multitaskingunmatched

Organizational Skillsunmatched

Pharmacovigilanceunmatched

Pinnacleunmatched

Presentation/Verbal Skillsunmatched

Problem Solving Skillsunmatched

Process Improvementunmatched

Program Planningunmatched

Project Developmentunmatched

Project Planningunmatched

Project/Program Managementunmatched

Quality Metricsunmatched

Regulationsunmatched

Regulatory Requirementsunmatched

Regulatory Submissionsunmatched

Risk Analysisunmatched

Risk Managementunmatched

SAPunmatched

SQL (Structured Query Language)unmatched

Software Administrationunmatched

Software Engineeringunmatched

Statistical Analysis System (SAS)unmatched

Statistical Programming Languagesunmatched

Statisticsunmatched

Strategic Planningunmatched

Team Playerunmatched

Technical Leadershipunmatched

Time Managementunmatched

Traceabilityunmatched

Training/Teachingunmatched

Writing Skillsunmatched

Description

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.
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.

Requirements:

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.

Associate Director, Biostatistics Clinical Dynamix, Inc.

Burlington, MA9 days ago

Lead statistical Programmer

Katalyst Healthcares & Life Sciences

Skills

Description

Numbers & Facts

Resume Resources

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Associate Director, Biostatistics Clinical Dynamix, Inc.