Manager Clinical Programming

MoonLake Immunotherapeutics; Cambridge; On-site; GBP 60,000 - 80,000; Full time

Job summary

A clinical-stage biopharmaceutical company in Cambridge is seeking a Clinical Programming Manager to lead and support clinical trial analysis. The individual will oversee internal programming activities and mentor junior staff while ensuring high-quality data outputs. The ideal candidate has a degree in a relevant discipline and experience with SAS programming. Strong leadership and communication skills are essential for this role.

Qualifications

• Degree in a related discipline.
• Experience with SAS programming.
• Understanding of clinical trials and CDISC standards.

Responsibilities

• Lead programmer for clinical trials.
• Mentor junior Clinical Programming members.
• Contribute to SDTM and ADaM datasets.
• Oversee vendor programming activities.
• Develop data review tools.

Skills

SAS programming

R programming

Clinical trials understanding

Leadership

Communication skills

Education

Degree in Computer Science, Mathematics, Statistics, or related disciplines

Job description

The Manager will lead and support the analysis and reporting of MoonLake sponsored clinical trials by directing and contributing to internal programming activities and overseeing external programming activities to ensure high-quality data, datasets, and statistical outputs.

Responsibilities:

1. Lead programmer for MoonLake sponsored clinical trials/indications, acting as the primary Clinical Programming point of contact.
2. Provide guidance and mentorship to junior members of the Clinical Programming group.
3. For internal studies, lead and contribute to the specification, production, and validation of SDTM and ADaM datasets, Tables, Figures, and Listings (TFLs) in support of planned and exploratory analyses.
4. For outsourced studies, oversee and review vendor programming activities and deliverables.
5. Develop data review tools to support in-stream data review.
6. Collaborate effectively with other Clinical functions (e.g., Medical & Drug Safety, Clinical Operations).
7. Ensure timely and accurate documentation of Clinical Programming activities (e.g., program headers, validation logs).
8. Maintain awareness of, and ensure compliance with, MoonLake policies and procedures.

Qualifications:

• Degree in Computer Science, Mathematics, Statistics, or related disciplines.
• Experience and understanding of clinical trials and CDISC standards.
• Experience with SAS programming; R programming experience is an advantage.
• Experience leading programming teams at the study and/or project level.
• Good oral and written communication skills.
• Highly organized, able to prioritize work and meet deadlines.
• Independent, self-starter with a proactive, problem-solving approach.

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on developing sonelokimab, a novel investigational Nanobody for inflammatory diseases. Founded in 2021 and headquartered in Zug, with hubs in Cambridge & Porto, the company is progressing in its global clinical development programs targeting conditions like hidradenitis suppurativa and psoriatic arthritis, which affect millions worldwide.