Associate Statistical Programming Director
Location: United States | Full-Time | Remote/Onsite (Depending on Company Policy)
Position Summary
The Associate Statistical Programming Director leads statistical programming activities across clinical studies and development programs. This role is responsible for developing, validating, and managing high-quality statistical programming deliverables using SAS and other software tools. The position includes oversight of SDTM and ADaM datasets, TLFs, automated analytics, and regulatory submission components. The successful candidate will partner closely with Biostatistics, Clinical Data Management, and external CRO teams to ensure data consistency, regulatory compliance, and timely delivery of clinical outputs.
Key Responsibilities
Serve as macro librarian and maintain global programming macros, workflows, documentation, and training materials.
Lead SDLC-compliant development of new global macros and standard programs to support departmental needs.
Independently develop SAS programs and specifications for study analyses, including Integrated Safety Summaries.
Collaborate with Data Management and Biostatistics to coordinate data transfers and delivery of required outputs.
Provide project-level programming leadership, identifying resource needs and overseeing programming activities across teams.
Oversee CRO development of ODS, SDTM, and ADaM datasets, including detailed documentation and specifications.
Provide programming quality control oversight for analysis datasets and TLFs produced by CRO teams.
Ensure defensive programming practices, accuracy checks, and adherence to FDA, CDISC, and company guidelines.
Manage ad-hoc programming requests and support technical problem-solving across multiple projects.
Contribute to departmental infrastructure, including process improvements and standardization efforts.
Assist with training new team members on macros, standards, and project-specific requirements.
Communicate effectively with cross-functional and external stakeholders.
Consistently meet project timelines and manage competing priorities.
Supervisory Responsibilities
This position does not include direct supervisory responsibilities but may guide or oversee the work of other programmers.
Required Education and Experience
Education Requirements:
BS/BA degree in a relevant discipline with minimum 11 years of experience; or
MS/MA degree with minimum 9 years of experience; or
PhD with minimum 5 years of experience; or
Equivalent combination of education and experience.
Professional certification in statistical programming is preferred.
Experience Requirements:
Minimum 8 years of programming experience in the pharmaceutical or biotechnology industry.
Strong proficiency in SAS/Base, SAS/Stat, and SAS/Macro programming.
Experience with UNIX, CDISC standards, and SAS graphics is desirable.
Oncology trial experience is an advantage.
Prior involvement in NDA or regulatory submissions is preferred.
Knowledge, Skills, and Abilities
Extensive expertise in statistical programming within clinical research.
Strong understanding of technical principles, concepts, and industry practices.
Ability to generate high-quality deliverables, resolve complex issues, and apply creative problem-solving approaches.
Excellent communication skills, both written and verbal.
Ability to guide junior staff, coordinate cross-functional work, and manage project-level responsibilities.
Strong analytical thinking and ability to interpret complex datasets.
Demonstrated capability to work independently, manage multiple priorities, and meet organizational deadlines.
Job Complexity
Works on complex and multi-dimensional problems requiring advanced evaluation of data and methodologies.
Exercises sound judgment within broadly defined policies and guidelines.
Applies industry expertise to solve diverse technical challenges.
Builds strong networks with key internal and external stakeholders.
Compensation and Benefits
Compensation is aligned with U.S. geographic market standards.
Base Salary Range: USD 162,500 – 230,500 annually.
Final compensation is based on geographic region, experience, skills, and internal equity.
Total Rewards Include:
Comprehensive health, dental, and vision insurance
401(k) plan with company contributions
Life and disability insurance
Flexible spending accounts
Annual discretionary bonus program
Stock purchase and long-term incentive opportunities
15 vacation days in the first year
17 paid holidays including winter shutdown
Up to 10 sick days annually
Disclaimer
This job description outlines the general responsibilities and qualifications for the role. It is not intended to list all duties or requirements that may be assigned.
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