GLOBAL PRINCIPAL BIOSTATISTICIAN
BRIEF COMPANY PROFILE
Our client - ALK-Abelló A/S - is a global, research-driven pharmaceutical company focusing on the development of prescription-only-medicines, and they are a global market-leader within their therapeutic area.
The company headquarter is in Hørsholm, Denmark with subsidiaries, production facilities and distributors worldwide.
In the role you will be end-2-end global responsible for two key products with primary focus on North America and Europe and is expected to provide statistical input to clinical development plans, trial designs, clinical trial protocols, briefing books, summary documents and publications. The role will be responsible for generating, presenting and discussing trial results with both internal and external collaborators and act as statistical expert, while interacting with regulatory authorities, partners and key opinion leaders.
The role offers the opportunity for exerting influence and impact on a strategic level – e.g. by influencing clinical trial design, clinical development plans and regulatory strategies. Moreover, the role offers the opportunity to take a key position in Q&A sessions with authorities.
Global Principal Biostatistician
Global Head of Biometrics
Greater Copenhagen, Denmark.
Responsibilities & Tasks:
Providing statistical input to clinical development plans, trial designs, clinical trial protocols, briefing books, summary documents and publications.
Generating, presenting and discussing trial results both internally and externally collaborators.
Influencing clinical development plans and regulatory strategies.
Interacting with regulatory authorities, partners and key opinion leaders, as statistical expert.
Planning and coordinating standard and high-level statistical tasks as well as driving the utilization of statistical tasks via SAS macros.
Working closely together with Biostatisticians, Statistical Programmers and Data Managers in the department and being a part of cross-disciplinary development teams.
Designing, maintaining and documenting procedures, including methods and summary/conclusions.
Communicating statistical issues and ideas to non-statisticians.
Key success criteria:
Ensuring that appropriate programs and documentations are developed for dataset development and output generation and ensure that statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
Delivering high-quality technical written reports of findings and conclusions, as required.
Successfully contributing to driving a high-performance culture based on a proactive and pragmatic mindset focused on adding value to the collaboration with key stakeholders.
M.Sc. -level (or above) degree within statistics, biostatistics, mathematics or related field.
English – fluent (verbally and written).
Ideal experience and competencies:
5+ years of experience from the pharma/biopharma or Medtech/IVD industries or from CRO’s.
A solid theoretical background in statistics corresponding to graduate level or equivalent.
Profound knowledge of SAS programming as well as statistical regulatory guidelines in North America and Europa
Knowledge of CDISC requirements for regulatory submissions is an advantage.
Divides problems into relevant parts; sensitively integrates the analytical output into the given context; differentiates between key areas and irrelevant and less important areas; has a logical mind-set; makes sensible decisions on the basis of available information; is able to get an overview of a specific situation and at the same time work detailed with a problem; uses details to gain an overview of a situation.
Can handle multiple priorities while being conscious of time in relation to work and effort, plans tasks in relation to time spend, and meets deadlines.
Is team oriented, works well with others with a view to obtain common objectives, shares information, resolve issues and improve efficiency; supports others and acts in a highly professional manner, seeing solutions rather than limitations.
Thinks or deals with problems or issues in a practical and sensible way suitable to the present conditions.
Is independent, self-assured, has a realistic belief in own abilities to take suitable measures in the execution of tasks, expects success regarding own initiatives, able to maintain momentum in case of adversity.
Involvement, commitment and prioritization
Participates actively in considerations, decisions and actions, offers own opinion and makes own abilities available, while assessing the importance of decisions and actions with analysis of the most important issue first.
Makes rational, realistic and sound decisions based on the involvement of available facts and possibilities and is capable of making sound decisions.
Has excellent technical writing and verbal communication skills with a high level of proficiency in English. Produces written material that is clear, fluent, engaging and easy to understand. Has excellent cross-cultural communication and presentation skills and communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep recipients' attention and is attentive to the needs of others when speaking.
Works systematically, organizes work and effort, is methodical in one's performance and holds on to commenced tasks and projects.