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Under the leadership of a Project Statistical Programmer, function as a Lead Statistical Programmer for one or more clinical trials and / or other global project sub tasks, across one or more clinical development programs. With guidance able to retrieve and understand regulatory requirements. Knowledge of and ability to apply CDISC SDTM and ADaM standards. For assigned tasks / trials, ensure CRO oversight in ensuring deliveries meets project needs and expectations; ensure efficient development of code and efficient and effective allocation of work. Ensure that all functional activities under one’s responsibility and / or supervision are performed to meet the defined timelines and quality expectations.
Demonstrate leadership in delivering in a matrix organization towards both the project (including Statisticians and other statistical programmers involved in the program(s)) and the global Biostatistics Function (support best practice, drive innovation, adhere to processes).
Specific Job Description:
Under the supervision of a Project Statistical Programmer, function as a Lead Statistical Programmer for one or more clinical trials and / or other global project sub tasks, across one or more clinical development programs.
• As a lead statistical programmer
- Coordinate statistical programming aspects of trials or other project subtasks.
- Provide input, via Project Statistical Programmer, to project level resource and timeline planning
- Delegate work to and manage assigned team members;
- Ensure delivery progresses according to desired timelines and quality, keep Project Statistical Programmer informed, liaising regarding the need to adjust timelines or resource plans as appropriate.
- Ensure expectations are clear to any team members under own supervision, and that communication and tracking of progress is effective.
- Perform technical planning and oversight of programming to ensure efficient coding (e.g. use of standard code, code is clear and reusable) and efficient allocation of work.
- Ensure team members are aware of relevant standards and processes and comply with them.
- For tasks/trials as allocated, ensure that the planning and management of outsourced statistical programming owned deliverables are effectively performed and are conducted to sufficient quality to meet business needs, and in a timely manner. With some direction, aid the CRO with prioritization of work when necessary in order to meet business needs.
• Ensure relevant standards are applied consistently.
• With some direction ensure maximization of global integratability and interpretability of data. Coordinate with Data Management and Clinical Operation to target high quality databases and specifications at trial level as assigned.
• Work closely with colleagues in interface roles (e.g. Project Data Manager, Project Statistician), to ensure smooth and efficient running of the project.
• Without direction, efficiently perform (and direct teams to perform) complex trial and with direction project level programming tasks, from set up to project close, with all tasks to high quality and efficiency.
• Able to quickly and effectively integrate into different project teams if needed.
• Responsible for ensuring statistical programming deliverable timelines and quality expectations are met and best practices implemented. Ensures appropriate level of CRO interaction and surveillance.
• Participate in Statistical Programming / Biostatistics initiative teams as required.
• Provide expert statistical programming advice / guidance and training to trial teams as needed.
• Effectively communicate statistical programming strategy, requirements, conventions, standards, and direction to Global Biostatistics and non-statistical programming internal and external colleagues
• Provide Subject Matter Expertise (SME) to project teams and other functions as required.
• Understand, follow and ensure adherence to, all Global Biostatistics WIs/SOP as well as any other relevant WI/SOPs.
• Keep abreast of SAS and other relevant technical enhancements and bring knowledge to the department. Demonstrate creativity in solutions which add value to the company. Contribute to process and technical improvements within Global Biostatistics.
• Contribute to Statistical Programming / Biostatistics process or technical improvement initiatives without direction.
• Develop technical statistical programming strategy for assigned tasks, in order to ensure efficient and compliant deliverables.
• May be responsible for contributing to key deliverables for a submission to regulatory authorities
• With some supervision review statistical programming trials / tasks budgets, relevant assumptions, and change orders.
• Review and approve timesheets of project team Functional Service Provider (FSP) staff to ensure that time spent is in line with expectations
Scope of people responsibility:
• Leads a virtual team of Statistical Programming and / or CRO staff. Provides standards, sets expectations, evaluates outcome against those expectations. For internal and FSP staff, handles day to day staff management issues, including resource management and allocation of work.
• In consultation with line managers where appropriate, thoughtful management of assigned project team members allocation of responsibilities and tasks to balance project needs with development needs.
• Participate in the hiring of CRO FSPs based on business need.
Required professional experience and necessary training:
• BS or MS in a numerate discipline, preferably Statistics, or Mathematics or Computer Science
• Fluent in English (written and spoken)
Necessary professional experience:
• Proven success, including some coordination or leadership Statistical Programming role within clinical development at a pharmaceutical or Biotech Company, or at a CRO, equivalent to minimum of 5 years directly relevant experience. Professional experience in an international environment is beneficial.
• Good understanding of drug development , including knowledge of interfaces and interdependencies with other functions
• Good working knowledge (or ability to obtain) of applicable therapeutic areas and statistical concept and relevant regulatory and data submission guidelines.
• Experience of working with SDTM datasets and of creating ADaM datasets and specifications, including development of integrated databases. Demonstrated competence in considerations for efficient technical planning.
• Demonstrated good project management skills.
• Proficiency in SAS. Expertise in SAS/BASE, SAS/STAT, SAS/MACRO, SQL, SAS/Graph
Job-specific competencies & skills:
• Demonstrates knowledge of ICH and CDISC SDTM and ADaM standards and able to retrieve and understand other relevant regulations / guidance documents ( eg from ICH, FDA, EMEA).
• Good leadership competencies, interpersonal and organizational skills, able to lead and guide teams to successfully deliver on project commitments, whilst maintaining positive problem solving approach and team engagement.
• Able to work effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups.
• Ability to educate the team’s interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements.
• Shows clarity of thinking and composure when under pressure, with some guidance, demonstrates confidence to reach a clear decision without deflection from unnecessary factors, i.e. identify critical path, tools and resources. Awareness of broader impact of individual decisions on Global Biostatistics and other functions.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com