Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The U.S. Food and Drug Administration has recently granted PEPAXTO (melphalan flufenamide, also known as melflufen), accelerated approval in relapsed or refractory multiple myeloma. Melphalan flufenamide is the first drug originated from the Company´s proprietary PDC-platform and is evaluated in a comprehensive clinical study program, including the ongoing phase 3 OCEAN study. Melphalan flufenamide is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma. The drug uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound. Due to its high lipophilicity, it is distributed into the cells. Melphalan flufenamide is designed to leverage aminopeptidases, enzymes which are overexpressed in myeloma cells and cause the release of the cytotoxic agents in the cells.
Oncopeptides´ global Headquarters is in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. Today the company consists of 250+ co-workers in Europe and USA.
We are looking for a statistical programmer to join our growing biometrics team, currently consisting of 14 people. The position is a full-time employment, and you will report to our Head of Biometrics. The role is in Stockholm, but remote work is also possible.
As a statistical programmer you will be supporting internal programming related activities for analysis and reporting along with review of datasets and associated documentation in Oncopeptides clinical studies. This includes working closely with cross-functional study teams such as clinical data managers, clinical operations managers/directors, study physicians, safety physicians and regulatory affairs managers. The role is for you who wants to work in a fast growing and dynamic company that is dedicated to make a big difference to patient lives.
Develop and review of analysis-ready datasets, tables, listings and figures and associated documentation, in close collaboration with statisticians and clinical data managers.
Contribute to development of departmental strategies that include but are not limited to data extracts, data programming and data standardization across Oncopeptides clinical studies.
Support data-driven processes for risk-based/centralized monitoring, in close collaboration with statisticians and clinical operations, across Oncopeptides clinical studies.
Participate in the development and implementation of process improvements and standard operating procedures.
Required Background, Skills, and Knowledge
At least 5 years’ experience from SAS programming work in clinical research in pharmaceutical industry. The following experience is also preferrable:
Management and vendor oversight of programming activities in clinical studies.
Knowledge of CDISC data standards
Familiar with FDA, EMA and ICH guidelines and regulations
Experience from various phases in clinical development and preferably oncology endpoints
Good experience with SAS programming
Excellent problem-solving skills.
Positive and solution-oriented personality.
Good cooperation and communication skills.
We are looking for a person with a university degree in computing, life science, mathematical or statistical subject.
Please send your CV and cover letter to SE.email@example.com and write Statistical Programmer in the subject line. We handle screening and selection continuously and therefore encourage you to apply as soon as possible. Start-date will be according to agreement. All enquiries are treated confidentially and will be handled in accordance with GDPR.
For further information regarding the role please contact Hanan Zubair, Head of Biometrics, at firstname.lastname@example.org. If you have questions regarding the recruitment process, please contact Johanna Tysell, HR Coordinator, at email@example.com.