Director Biostatistics - Scandinavian Biopharma, Solna
Are you a senior biostatistician and want to make an impact and contribute to global health?
We are recruiting a Director Biostatistics to Scandinavian Biopharma, a research-based speciality biopharma company with experts in global vaccine development, manufacturing, registration, and marketing of pharmaceuticals. The company is developing the first vaccine for protection against diarrhea caused by Enterotoxigenic Escherichia coli (E. coli), or ETEC.
Infection with ETEC is the leading cause of travelers’ diarrhea and a major cause of diarrheal disease in low and middle-income countries, especially among children under the age of five. Positive results from on-going and finished studies are accelerating the development of the company´s tailor-made vaccine presentations for infants in low to middle income countries. The vaccine candidate potentially could save hundreds of thousands of lives per year and prevent immense physical suffering and malnutrition due to repeated bouts of illness as well as detrimental effect on poverty in these countries. The vaccine will also prevent long-term gastrointestinal syndromes due to diarrheal infections following travel, saving millions of holiday trips and reducing the disease burden of military and health workers in deployed ETEC-endemic countries.
As Director Biostatistics you will belong to the Clinical Development Team and be the company's overall responsible statistician in strategic and operational decisions in relation to clinical development plans. You will report to the VP Clinical Development and the office is located in Solna.
Main responsibilities and tasks:
Provides Biostatistics expertise in operational and strategic decisions.
Providing statistical leadership, support and alignment for e.g. study designs, study deliverables and documentation including CRO oversight and manuscripts.
Providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.
Relevant background and experience:
A Master’s degree in Statistics/Biostatistics and 15+ years of relevant pharmaceutical experience. A PhD will be a strong asset but key focus will be a strong pharmaceutical development background, ideally from both big pharma and smaller organizations
Comprehensive knowledge of statistical methodology in design and analysis of clinical trials.
Experience of CRO oversight.
Strong analytical and empirical skills for interpreting data and informing decision- or policy- making.
Ability to collaborate with people across multiple areas of expertise with an open-minded and positive approach.
Excellent verbal and written communication skills.
I vårt förhållningssätt tillämpar vi inte enbart den grundläggande etiken att inte göra fel utan vi arbetar med vad vi benämner en proaktiv etik, att göra det rätta och att göra gott. Ingen information förmedlas vidare utan uttryckligt godkännande från berörd part.
Haeger & Carlsson Executive Search and Interim söker inte aktivt upp kandidater hos de företag där vi har en etablerad kundrelation.