Affibody is expanding its clinical development programs, moving into Phase 2 and 3, and therefore sees a need to develop and strengthen the company’s capabilities within biostatistics. Affibody is currently looking to recruit an experienced biostatistician to take on a key role in the design and interpretation of Affibody’s global drug development programs. The role will report to the Head of Clinical Development and is located at our newly established premises in Solna, Sweden.
The role in general
In our overall strive to build clinical development programs that maximizes the potential of Affibody’s compounds you would as a Biostatistician be expected to provide highly qualified statistical, scientific and strategic input both as a member of the project teams across all phases of drug development and directly to line functions (e.g. clinical safety, clinical pharmacology, immunogenicity, pre-clinical). As Biostatistician you would further engage in analyses to exploit information to improve design and decision-making and support in benefit, risk, value and uncertainty assessments. The role involves responsibility for components of regulatory submissions including specification and construction of overview documents and responses to regulatory questions and health technology assessments.
- Responsible for statistical input to the establishment of focused, aligned and achievable Target Product Profiles (TPPs) and Target Product Claims (TPCs)
- Responsible for statistical input to the design and preparation of Drug Development Plans (DDPs)
- Responsible for statistical input to relevant documents in regulatory submissions, e.g. eCTD
- Take a pro-active role and provide strategic input for the design of innovative trials and programs, including adaptive trial design, Go/No Go criterion and associated risk levels
- Responsible for the statistical content of Clinical Trial Protocols
- Responsible for Statistical Analysis Plans for trials and regulatory submissions
- Responsible for the statistical analysis and contribute to the interpretation and reporting of trial data
- Participate in preparing responses to regulatory questions
- Provide statistical and strategic input into other regulatory documentation, e.g. IB, DSUR and DRMP
- Provide statistical support to the development of non-clinical efficacy and safety studies
- Contribute to the writing of publications and abstracts, in accordance with the publication strategy for the project, as applicable
- Ensure high quality statistical support for projects through the evaluation of CRO suppliers, and provide input into outsourcing strategy and processes
- Identify and collaborate with external statistical experts (including vendors and consultants) as needed
- Stay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings
The right candidate fulfills the following qualifications:
- Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent, a Master degree in the same areas is a plus
- A minimum of 5 years of experience as a statistician in the pharmaceutical industry
- Sound knowledge of theoretical and applied statistics
- Comprehensive knowledge of clinical and pharmaceutical drug development
- Experience working in several phases of clinical development
- Ability to explore and develop innovative approaches to trial design and analysis
- Sound understanding of the regulatory environment within clinical development
- Experience with regulatory interactions and submissions is desirable
- Experience with statistical programming in SAS is desirable
- Excellent verbal and written communication skills in English
- Strategic thinking
- Ability to clearly communicate statistical information to non-statisticians
- Strong ability to collaborate and contribute in cross-functional teams
We are looking for a highly experienced, scientific-oriented and well-organized individual who is able to work independently, as well as in teams. To be successful in the role you need to be flexible and willing to contribute to the delivery of project tasks and objectives, including tasks outside your key expert area in a multidisciplinary environment. You can see the bigger picture, are analytical and seek new knowledge to provide sound solutions to problems. You are able identify with whom to communicate and interact. The role requires both operational activities and strategic oversight. You have the ability to prioritize in order to deliver business critical items in time.
In this recruitment we are collaborating with Haeger & Carlsson. Please apply through www.haegercarlsson.com. If you have any questions about the role, please contact Gunilla Haeger, 070-461 93 87, firstname.lastname@example.org.
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Affibody in short
Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
Upcoming reports Financial calendar
- Interim Report January to March 2020 (May 15, 2020)
- Interim Report January to June 2020 (August 21, 2020)
- Interim Report January to September 2020 (November 13, 2020)
- Year End Report 2020 (February 2021)