Senior Principal Statistician
12 Month contract
Paying up to 450 a day
Good understanding of drug development, regulatory requirements, ICH and HA guidelines
Excellent knowledge of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software.
The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned studies in collaboration with the clinical trial team.
- Responsible and accountable for the statistical activities and support on statistical solutions for trials/publications and conferences and support the tasks independently seeking peer inputs/ reviews as required. Activities include protocol development in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, design and reporting of mid to high complexity trials/experiments, and production and delivery of statistical deliverables and exploratory analyses. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Group Head, Biostatistics.
- Propose and lead statistical/numerical/analytic research by providing advice and solutions on computational aspects of the problem.
- Guides the trial statistician to ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for all studies.
- Maintain effective interfaces with internal and external customers with advice from Principal Biostatistician and the Principal Statistical Programmers, CRO and CPOs as required.
- Assume responsibility and accountability for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical studies and scientific analytical solutions.
- Provide guidance to trial statisticians and ensure compliance with project/study standards and specifications following internal guidelines.
- Oversee Biostatistics resources and deliverables for assigned trials and therapeutic area level. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned studies and/or non-clinical related activities.
- Explain statistical methodology and interpret analysis results. Provide statistical expertise to support all activities and documents, meetings with and responses to customers and JOC meeting activities, as required.
- Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians, and provide adequate statistical justifications for actions/decisions/statements, when required.
- Support quality control and quality audit of deliverables.
- Provide input on process improvement initiatives and participate in non-clinical project activities with support from group head.
- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Identify, evaluate and promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations and chairing sessions at professional meetings.
- Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
- Excellent knowledge of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software
- Good understanding of global clinical trial practices, procedures, methodologies and deep knowledge of data architecture
- Statistical and numerical knowledge and expertise in analytic aspects and applications in clinical trials; able to explain the statistical designs and concepts.
- Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives.
- Good understanding of drug development, regulatory requirements, ICH and HA guidelines
- Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions.
- Good business ethics
- Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role.
If you are interested please apply or send your cv directly to firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Contact: Luke Sandilands
- Reference: JO-2111-479953
Website: Cpl Life Sciences
- Posted: 11th November 2021
- Expires: 9th December 2021