Senior Director Jobs In UK, As Senior Director, Global Head of Biostatistics, you will have overall responsibility and accountability for a Biostatistics and Statistical Programming team as it relates to all stages of development for pharmaceutical products including the clinical related components of protocols, study reports, regulatory submissions, clinical trial applications or new drug/marketing authorization applications, and post-marketing activities including publications. The role will also support the design and reporting of medical nutrition studies.
This position and team members represent Biometrics on the clinical and project teams providing subject matter expertise and strategic direction for clinical programs. The Senior Director, Global Head of Biostatistics is expected to provide oversight and supervision of relevant external consultants as it relates to external data management.
Statistical and programming work as well as supervising internal biostatistics and/or programming personnel to analyze and present data based on agreed-to specifications and analysis plans. You will develop, create, verify/validate and maintain all programs for assigned projects in compliance with standard operating procedures.
|Post Name||Senior Director|
|Qualification||Master’s degree in Statistics, Mathematics|
|Employment Type||Full Time|
|Work Hours||8 Hours|
|Salary||GBP 4400 TO 4800 Per Month|
|Location||London, England, United Kingdom W2 6LG|
This is a permanent opportunity and here at Nestlé many of our colleagues work flexibly and in many different ways, with different core hours and remote working. Please talk to us during the recruitment process about what flexibility could look like for you.
What we offer at Nestlé
Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could look like for you! Genuine opportunities for career and personal development Modern “smart office” locations provide agile & collaborative workspaces Dynamic international working environments Attractive additional benefits
A day in the life of a Senior Director, Global Head of Biostatistics
- Responsible for statistical, and statistical programming activities associated with clinical research studies across all stages of drug development and with programs leading to regulatory submissions and generation of other clinical scientific data reports, publications, or disclosures
- Develop and manage appropriate internal team members plus external statistical or programming consultants to support clinical research programs and regulatory submissions
- Maintain full-scope responsibility for assigned projects: ensure on-time delivery, communicate the status of projects to internal teams and vendors, execute quality assurance procedures on work produced by others and ensure statistical analysis is being undertaken according to agreed specifications
- Define, drive and prepare (or supervise the preparation of) statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Clinical Protocols, Briefing Books, IND/CTA/NDA/MAA documentation, and Regulatory Responses).
- Provide guidance in the development and implementation of data management and statistical programming standards and ensure that the standards are followed
- Lead the development and adaptation of new statistical methodology in support of drug research and development, keeping current with regulatory guidance and requirements in the global environment
What will make you successful
- Master’s degree in Statistics, Mathematics, or related field required; Ph.D. preferred
- Relevant clinical and pharmaceutical industry experience in the planning and conduct of clinical trials
- 5+ years managing the Biostatistics and Statistical Programming functions preferred
- 10+ years of related experience working in the biotech/pharmaceutical industry.
- Proven history of effectively contributing to the business plan at both the tactical and strategic levels.
- In-depth knowledge of the global drug development process including extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and procedures, and other international regulatory requirements
- Proficiency in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS, and other relevant statistical software
- Advanced understanding of the development, programming, management, validation, and documentation maintenance of all programming tasks
- Ability to lead a team with regards to ongoing development in terms of both personnel development and departmental methodologies and techniques
- Demonstrated problem-solving skills (including taking ownership to ensure timely resolution) and a strong sense of urgency, keen attention to detail, and the ability to successfully execute across multiple programs and timelines
Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Headquartered in Switzerland, we have more than 11,000 employees worldwide, with products available in more than 140 countries.
Aimee Therapeutics is the pharmaceutical unit of Nestle Health Science (NHS), with a focus on the advancement of treatments for food allergy, GI disorders, and other food-mediated diseases. We are continuing to build a world-class R&D organization with a strong development infrastructure to support programs in gastroenterology, food allergies, and other metabolic & inflammatory diseases. The R&D function within Aimmune Therapeutics drives development activities related to the pharmaceutical pipeline.