Associate Director, Programming Statistical Computing Environment at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Programming Statistical Computing Environment in United States.

This role sits at the core of a regulated, global statistical programming ecosystem supporting advanced scientific and clinical research. The Associate Director is responsible for overseeing a validated Statistical Computing Environment used across statistical programming and biostatistics functions. Acting as the Business System Owner, this position ensures the platform remains compliant, secure, and fit for purpose within strict GxP requirements. The role combines technical oversight, regulatory accountability, and strategic roadmap leadership to evolve a SaaS-based computing environment. It involves close collaboration with IT, Quality Assurance, vendors, and cross-functional scientific teams. The position plays a key role in enabling reliable, scalable, and inspection-ready statistical computing capabilities. It is ideal for a professional who thrives in highly regulated, data-driven, and collaborative biotech environments.

• Serve as Business System Owner for the Statistical Computing Environment, ensuring its validated state and regulatory compliance in partnership with IT, QA, and external vendors.
• Lead validation lifecycle activities, including change impact assessments, user acceptance testing, regression testing, and approval of validation deliverables.
• Oversee vendor system releases and changes, ensuring proper risk evaluation, documentation updates, and controlled deployment readiness.
• Conduct periodic system reviews covering access governance, compliance status, and ongoing fitness for intended use.
• Manage deviation handling and CAPA activities related to system functionality and compliance risks.
• Ensure inspection readiness and adherence to global regulatory frameworks, including GxP, data integrity, and validation standards.
• Define and prioritize the platform roadmap aligned with statistical programming and clinical development strategy.
• Provide operational oversight, end-user support, training, and adoption of system enhancements.
• Partner across IT, Digital, QA, and business stakeholders to enable integrations and system interoperability.
• Support audits and regulatory inspections as the primary business representative for the platform.

• Bachelor’s or Master’s degree in statistics, biostatistics, computer science, or related field, or equivalent experience; 10+ years in pharmaceutical or biotech environments.
• Proven experience as a Business or Application System Owner for validated GxP systems, ideally in SaaS or cloud-based environments.
• Strong knowledge of regulatory frameworks including 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, and GxP SDLC principles.
• Experience leading validation activities such as UAT, regression testing, change control, and vendor documentation review.
• Background in supporting audits, inspections, and regulatory compliance activities.
• Familiarity with statistical programming environments such as SAS or R, including workflow and package management concepts.
• Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities.
• Experience working in vendor-managed validation models and assessing SaaS release impacts.
• Strong collaboration and communication skills, with the ability to work across technical and scientific teams.
• Exposure to open-source governance or industry initiatives (e.g., PHUSE, CDISC) is a plus.

• Competitive salary range: $164,080 to $246,120
• Eligibility for annual performance-based bonus and long-term incentives
• 401(k) retirement plan with company match
• Comprehensive medical, dental, and vision insurance options
• Health Savings Account (HSA) for eligible plans
• Paid vacation, sick leave, and holidays
• 12 weeks of paid parental leave
• Flexible working model supporting remote and hybrid arrangements
• Life, accident, and disability insurance coverage
• Tuition reimbursement and professional development support
• Wellness resources, family support programs, and backup care services
• Commuter benefits and lifestyle spending account