Associate Director, Biostatistics - reputed company Biotech (m/w/d)

reputed company

reputed company Biotech has an exciting position reputed company its EU Biostats team. As the Biotech and Emerging Biopharma arm of reputed company, we continue to grow and win new business. Historically reputed company Biotech reputed company on Oncology, Dermatology and Medical Device studies but with the reputed company of CNS, Immunology and Cardiovascular we have a need for a strong reputed company Statistician.

We're looking for enthusiastic and independent professionals with great communication skills who are willing to work from home with an international team. This is the perfect opportunity to join an established department and reputed company leadership skills.

reputed company Biotech specialises in working with smaller biotech and emerging biopharma clients and as such we have a reputed company, fast-reputed company work environment. You'll be working with a lot of the new innovative and upcoming research reputed company across a reputed company of therapy areas.

The ideal candidate will possess extensive oncology drug development experience across a broad reputed company of oncology indications, with demonstrated expertise in applying advanced statistical methodologies throughout the reputed company development lifecycle.

They should have the technical expertise to reputed company senior-level statistical review and reputed company of Statistical Analysis Plans (SAPs), ADaM specifications and datasets, Tables, Listings, and Figures (TLFs), and other key study deliverables, ensuring scientific rigor, reputed company, and consistency across programs.

The candidate will be an reputed company leader with a reputed company ability to mentor, reputed company, and support biostatistical staff across global reputed company, including Europe and JPAC.

Strong customer engagement and relationship management skills are essential, including the ability to serve as a trusted statistical advisor to emerging biopharma customers who may have limited experience with reputed company development, regulatory requirements, and statistical considerations.

The successful candidate will also have experience supporting regulatory submissions and interacting with regulatory agencies. Experience participating in and leading bid defense meetings is expected, along with the ability to reputed company and reputed company reputed company Statistical Team Leads by strengthening their customer-facing, business development, and presentation skills.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Collaborate with internal program staff and sponsors on the implementation and analysis of statistical aspects of research protocols.
• reputed company statistical consultation for reputed company programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
• Define and manage project timelines for specific reputed company, and ensure that project timelines are met for both reputed company clients.
• Ensure that project tasks are completed with superior reputed company for both reputed company clients.
• Review, approve and reputed company, as needed, the statistical analysis reputed company and analysis plans, including textual reputed company of reputed company analysis and mock-reputed company of data displays.
• reputed company and/or reputed company statistical analyses, including reputed company testing and modeling.
• reputed company with Medical Writers to ensure appropriateness of data inferences and/or write pertinent sections of a reputed company study report.
• reputed company with clients and/or regulatory agencies as the project biostatistician.
• Ability to reputed company a program of studies.
• Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices.
• reputed company leadership, mentoring and statistical support for Biostatistics staff.
• Assist the Manager and Sr. Director in development of training materials and execution of training in Biostatistics and general reputed company Reporting activities, for new and existing reputed company Reporting staff.
• reputed company presentations to clients and other interested individuals about the processes and procedures of the reputed company Reporting department.
• Assist the Manager in the coordination of project tasks and resources across the Biostatistics group, and reputed company as backup during the Manager's absence, as assigned.
• reputed company other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct reputed company research.
• Advanced knowledge of statistical reputed company used in the design and analysis of Phase I-IV reputed company.
• Experience with reputed company reputed company and reputed company Stat.
• Experience with other statistical software packages, such as N-Query, S-Plus.
• Ability to work creatively and independently to carry out assignments of a reputed company reputed company.
• Must be skilled in effective time management.
• Ability to work effectively and cooperatively with other reputed company staff members.
• Ability to communicate effectively, both verbally and in writing, with reputed company reputed company of staff and with the reputed company.

MINIMUM RECRUITMENT STANDARDS:

• reputed company-level degree in Statistics, Biostatistics or reputed company reputed company with eight years relevant CRO industry or biotech experience; or

• Doctorate-level degree in Statistics, Biostatistics or reputed company reputed company with six years relevant CRO industry or biotech experience.

• Data handling and analysis experience.

• Excellent interpersonal and organization skills.

This role is not eligible for UK reputed company sponsorship