Associate Director, Biostatistician

3 weeks ago

Aarhus N København Ø og mulighed for hjemmearbejde, Denmark NMD Pharma AS Full time
On-site in Aarhus or Copenhagen, Denmark, or Remote-based (US)

Join Us in Advancing Life-Changing Therapies

At NMD Pharma, we are committed to delivering life-transforming therapies for people living with neuromuscular diseases. As we continue to advance our pipeline into late-stage development, we are looking to recruit a Senior Biostatistician, who will play a key role in shaping our clinical development programs, ensuring robust statistical methodologies, and supporting regulatory submissions.

This is an exciting opportunity to work in a dynamic, and collaborative biotech environment, where your expertise will have a direct impact on our mission – to develop novel treatments to improve muscle function and quality of life for patients living with neuromuscular diseases.

Your Key Responsibilities

- Contribute to the clinical and regulatory development plans and strategies for specific projects.
- Collaborate with project teams to implement and execute biostatistics in clinical plans according to applicable guidelines to support marketing authorizations.
- Provide statistical expertise in the design, execution, and interpretation of clinical studies.
- Develop statistical analysis plans (SAPs).
- Contribute to the development of study protocols, CRFs, shells, clinical study reports, and other essential documents.
- Perform sample size calculations for clinical trials.
- Ensure data consistency and integrity in collaboration with Data Management.
- Lead statistical analysis and programming activities using SAS and R and/or oversee these activities when these are outsourced to contract research organizations (CROs).
- Support regulatory submissions to FDA, EMA, and other agencies.
- Stay updated on new statistical tools and methodologies and apply them to ongoing projects.
- Support other parts of the organization with statistical expertise.

What You Bring

- MSc or PhD in Biostatistics, Statistics, Mathematics, or a related field.
- 5+ years of experience in biostatistics for clinical trials in biotech, pharma, or CROs.
- Extensive experience working with CDISC/SDTM standards and statistical programming in SAS or R.
- Strong knowledge of early and late-stage trials (Phase 2 and 3).
- Experience with secondary database studies and real-world data.
- The ability to translate complex statistical concepts into clear, actionable insights.
- Excellent written and verbal communication skills in English.

Why Join NMD Pharma?

At NMD Pharma, we are passionate about movement, applying our expertise to turn science into novel therapeutics that enable patients with neuromuscular diseases to live better, more independent lives. As part of our organization, you will benefit from:

- Impact-driven work, where you will be part of a team dedicated to improving lives through innovative therapies.
- Flexible work arrangements, with the option to choose remote work (US/Europe) or on-site in Denmark.
- Highly collaborative culture, working alongside a highly skilled and cross-functional team where ideas turn into action.
- Inclusive and collaborative culture where new ideas are valued
- Competitive compensation package, along with structured career development pathways.

Ready to Apply?

Join us in advancing neuromuscular disease treatments. We look forward to hearing from you

Please note: Applications can only be processed through our Jobindex site.

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