Programming Manager

Job Summary

As a Programming Manager, you will work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. You will have excellent knowledge of CDISC, SDTM and ADaM implementation guidelines, allowing for the production, review and updating of complex macros. You will review Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs, along with output shells with a view to commenting from a programming perspective. You will have an excellent team work ethos, being proactive at managing workloads and willing to help others, learning new skills from working in a collaborative environment. As a line manager, you will contribute to management meetings.

The role will be full-time and fully remote, the successful candidate will be based in India .

Responsibilities

The following areas of expertise will be aligned to the role...

• Statistical expertise and scientific leadership
• Leadership and people development
• Compliance, quality and governance
• Communication and influence

Qualifications

Essential:

• Strong SAS programming expertise, including SAS/BASE, SAS/STAT, SAS/GRAPH and ODS. Experience with additional SAS modules, automation tools or other programming languages would be advantageous.
• Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
• Strong knowledge of CDISC standards, particularly SDTM and ADaM, including dataset specifications, implementation, validation and regulatory submission requirements.
• Experience leading statistical programming activities, including study planning, resource allocation, timeline management, quality oversight and technical review.
• Ability to provide technical guidance and mentoring to programmers while working effectively with statisticians, data managers and cross-functional study teams.

Preferred:

• Experience supporting complex efficacy analyses, including advanced statistical outputs, derived endpoints, sensitivity analyses and exploratory or post-hoc analyses.
• Experience leading programming activities for complex clinical studies, integrated analyses or regulatory submissions.
• Ability to work with overlap with US morning hours

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