The role of Associate Director, Statistics provides support to the Head of Statistics and members of the statistics function. The role includes line management of more experienced statisticians within the organisation, support in issue escalations, and pastoral care including careful guidance, leadership, training and mentoring. They will provide senior review and oversight of documentation and deliverables, ensuring they are delivered to optimal quality, on time and within budget. They will support project work as needed, and mentor junior staff. They will support the Head of Statistics to ensure the statistics function has the appropriate personnel and skills to complete their jobs effectively. They will support operational success of studies through careful planning and work assignments. They will provide input to quality processes through creation and review of SOPs, involvement in CAPA processes and ensuring implementation of quality processes. They will represent the statistics function at management meetings, and help to drive continuous improvement within the function and through collaboration with other functions. They will support business development and recruitment activities.

Employees may be required to perform some or all of the following:
· To assist the Head of Statistics in providing timely communication to the function
· Leadership of members of the statistical function within specific geographical regions
· Line manage senior members of staff within the statistics function, allowing individuals the opportunity to reach their full potential
· Training and mentoring line managers and less experienced members of staff within the Statistics function
· Support resolution of any issues escalated by or involving statistics team members
· Support the operational success of studies through careful planning and work assignments
· Helping the Head of Statistics identify areas of skill development for the statistics function as a whole
· Work closely with cross-functional Operational leadership team
· Communicate with management and senior leadership on progress, prepare reports and presentations, as needed
· Work with QA department to ensure risk management strategies in place
· Contribute to SOP creation and review
· Involvement in the CAPA process
· Ensure members of the statistics function implement and adhere to best practices and the PHASTAR checklist
· Identify areas that new statistical processes are required
· Work with Operational Excellence function to implement new processes developed within that function and ensure adherence to the new processes on an ongoing basis
· Monitor ongoing statistics function performance and look for improvements
· Motivate and inspire others
· Provide solutions/advice to issues/questions raised by team members
· Recruit, interview, hire and train new employees, as needed
· Identifying strategies to increase retention rate
· Provide statistical leadership and support to assigned studies as needed
· Provide and maintain a positive and engaging client relationship with regards to statistical issues
· Prepare and review study documentation including protocols and statistical analysis plans
· Manipulate, summarise and analyse clinical trial data using a variety of statistical methods
· Function as statistical lead and/or project lead across multiple studies
· Complete statistical activities on assigned studies as required
· Liaise with reporting teams and answer questions
· Report any potential new business opportunities to the business development manager
· Maintain visibility to external customers (e.g. white papers, blogs, LinkedIn posts etc)

· Educated to PhD or MSc in Biostatistics or a related discipline
· Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation.
· Familiarity with GCP and regulatory requirements
· Experience of writing SAPs, protocols & regulatory submissions
· CRO or pharmaceutical background
· Experience of working with CDISC data standards and performing statistical analysis using SAS
· Experience using various statistical modelling techniques
· Project leadership experience
· Line management experience
· Ability to communicate with a broad range of people across different functions

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

Important notice to Employment businesses/ Agencies

Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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