We are looking for experienced Statisticians at different seniority levels, who has a genuine interest in working with clinical data and experience with clinical trials and regulatory submissions. The job level and role will depend on your skills, qualifications and experience.
If this sounds like you, and you are ready to take on a broad area of responsibilities with an independent attitude, you are a match for us.
You will have a critical role in scientific and strategic discussions related statistical, clinical, and regulatory aspects of clinical drug development and in regulatory submission. You will be part of the Biometrics Department consisting of data managers, statistical programmers and statisticians. The department contributes to the overall clinical development strategy of Zealand’s compounds, the scientific integrity of the development programs and to interactions with regulatory authorities. Together we are responsible for ensuring scientific validity, quality of clinical trial data, data standards and oversight of outsourced Biometrics activities. The general business model at Zealand is that nearly all aspect of trial conduct is outsourced, however we strive to deal with NDA/MAA submission activities in-house.
Responsibilities
- Act as point of contact from Biostatistics in cross-functional project activities
- Ensure state-of-the-art statistical methodology and that trial decisions are evidence-based and data-driven
- Contribute to the authoring and review of trial outlines, statistical analysis plans, statistical deliverables for protocols and clinical trial reports including deliverables from CROs
- Interact with the internal team and CROs to ensure timely and quality statistical deliverables
- Drive the evaluation of clinical trial data, host and prepare trial key results meeting
- Ad hoc statistical analysis on individual trials and statistical analysis on program level e.g for regulatory submissions, regulatory requests or scientific publications
- Drive regulatory submissions from a Biostatistics perspective
Candidate profile
- Master’s degree or PhD in statistics or mathematics
- At least 10 years of experience within clinical development, experience within rare disease or obesity and with regulatory submissions would be an advantage.
- Experience with trial outline, protocol, SAP development or statistical analysis
- Previous experience working with SAS. R is a plus
- Experience with outsourcing of clinical trial activities would be an advantage
- Able to work independently as subject matter expert
- Proactive and open-minded team-player with good communication skills
- Ability to navigate in a smaller organization where priorities can change
Bonding to innovate
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities
To find out more about working at Zealand, visit https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than January 5th, 2025, or as soon as possible.
For further information, please contact Per Sørensen at PSO@zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or bond with us through LinkedIn.
