Senior Principal Statistician

Location: North Wales

** Job Description*
* In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

** Responsibilities**  **:*
* + Serves as a statistical lead in project teams.

+ Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.

+ Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

+ Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.

The incumbent may initially work in a specific disease area.

** Primary activities**  **:*
* + Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development

+ Lead a team of statistical and/or programing staff assigned to a development project as needed

+ Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.

+ Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.

+ Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.

+ May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements

+ Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.

+ Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.  Independently applies and implements basic and complex statistical techniques to these analyses.

+ Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Management, regulatory agencies, or individual investigators.

+ Represent biostatistics in regulatory interactions including presentation at advisory committee meetings

+ Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.

+ Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

+ Lead research activities for innovative statistical methods and applications in clinical trial development.

+ Collaborates in publication of research results in areas of applications.

+ Mentors and guides junior staff in functional activities.

+ Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed

** Education & Skills*
* Education and Minimum Requirement:

PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a master's degree with a minimum of 12 years relevant work experience.

Required

Skills and Experience:

+ Solid knowledge of statistical analysis methodologies and experimental design.

+ Strong scientific leadership in design and analysis of clinical trials

+ Strong project management skills.

+ Solid knowledge of statistical and data processing software e.g. SAS and/or R.

+ Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.

+ Excellent oral and written communication skills and strong leadership in a team environment.

+ Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.

+ Publications in peer reviewed statistical/medical journals.

+ Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred

Skills and Experience:

+ An understanding of biology of disease and drug discovery and development; experience in late-stage oncology development preferred, hematology a plus

BARDS
2020

eligibleforERP

*
* Required Skills:

*
* Biostatistics, Clinical Development, Clinical Trial Management Processes, Clinical Trials, Clinical Trials Analysis, Data Analysis, Data Management, Data Science, Hematology, Numerical Analysis,…