Statistical Lead

6 meses atrás

Porto, Portugal MoonLake Immunotherapeutics Tempo inteiro

**Job Purpose**:
**in this role you will be responsible for all statistical activities for a phase 3 indication. You will be responsible for the oversight and management of biostatistical activities to ensure high quality design, analysis and interpretation of MoonLake sponsored clinical trials.**

**Key accountabilities**:

- Statistical leadership for the design, analysis and interpretation of clinical studies, including the writing of the statistical sections of protocols, SAPs and study related activities.
- Statistical contribution to the planning, definition of the analysis methods and writing of regulatory submission documents for an indication.
- Oversight and review of vendor statistical activities, with accountability for study level timeliness and quality of statistical deliveries
- Act as key contact for biostatistics vendors to ensure effective communication between MoonLake and the biostatistics vendors.
- Provide statistical insight and exploratory analyses of completed and ongoing Moonlake studies.
- Provide effective communication and visualisation of data and statistical analyses within Moonlake and support for publications and presentations.
- Communicate progress and identify risks and issues arising on clinical trials to the Director of Clinical Operations and other MoonLake development team members as appropriate.

**Your profile**:
**Education**: Postgraduate degree in statistics or related discipline**:** Experience: 10+ years** experience of clinical biostatistics in the pharmaceutical/biotech industry

**Skills, knowledge/behavioural competencies**:

- Experience of managing outsourced biostatistics activities
- Experience of dermatology/rheumatology clinical trials would be an advantage.
- Robust knowledge of GCP and related regulatory standards for clinical biostatistics governing clinical trials in the UK, EU & USA
- Programming experience with SAS and/or R
- Excellent oral and written communication skills
- Ability to interpret, process and present data in innovative ways to meet the needs of multiple stakeholders
- Highly organised, able to prioritise work, work well under pressure and meet deadlines
- Independent, self-starter with a proactive, problem solving approach
- Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants
- Ability to see complex projects to completion, and to work on a broad range of tasks within a project

**Work Location**:

- 2 days a week in our brand new Porto office

**Why us?**:
**An exciting job opportunity awaits you**

MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.

**What we offer**:
**Learning Environment**: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

**Impactful Work**: Contribute to groundbreaking projects that have the potential to transform global healthcare.

**Flexibility and Balance**:Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.

**Career Growth**: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

**Our Core Values**

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
**We do Stellar Science**: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.

**We go beyond**: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.

**We unlock value**: We aspire to create long-term value for investors and communities.

**About us**:
**MoonLake Immunotherapeutics** **is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis - conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.

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