Principal Statistician (London, UK)
This position offers an outstanding opportunity to help drive the growth of
a successful and rapidly expanding business. Highly qualified professionals
play a key role in shaping the overall development of the company. In this
role you will have considerable scope for professional and personal
development. The remuneration package is commensurate with the significance
of the role and reflects the contribution expected.
CONTRACT: Principle Statistician - Biometrics & Data Management
UK Based, Excellent Salary + Benefits + Bonus
Job Summary:
The purpose of this position is to provide program / therapeutic area /
development phase statistical expertise and leadership;
* Designing, analyzing and interpreting clinical studies and programs conducted by US and EU.
* Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
* Standardizing study design, analysis methodology and presentations to maximize global data integration and inter-program efficiency.
* Leveraging external vendors providing statistical services to achieve quality, timely, cost-effective study deliverables.
* Independently representing Statistics function in interactions with regulatory authorities.
Accountabilities/Responsibilities:
* Represent the statistics function on global teams in support of clinical studies and programs led from either the US or EU.
* Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions.
* Provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents.
* Oversee definition and implementation of project level database (including derived database), analysis and reporting standards.
* Plan and direct program-level analysis and reporting activities including work of other statisticians and programmers.
* Identify program-level vendor requirements and participate in the evaluation/selection of BDM vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
* Identify and interact with external statistical experts for issues related to design, methodology and results.
* Anticipate and communicate resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
* Increase efficiency of the Statistics function through development of standard analysis methodology, data presentations and sharing of best practices. Lead the implementation of such standards and process improvements.
* Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses.
* Comply with all applicable regulatory requirements and Company standards and procedures.
Essential Skills & Capabilities:
* MS in statistics or biostatistics and x years of relevant pharmaceutical industry experience, or PhD in statistics or biostatistics with minimum of x years of relevant pharmaceutical industry experience.
* Experience on at least two global projects and at least two NDA / CTDs.
* Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, and data presentation practices.
* Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
* Knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
* Demonstrated success independently representing Statistics function in interactions with FDA including end of Phase II, pre-NDA meetings or advisory committee meetings.
* Good knowledge of statistical programming languages (including SAS), software, techniques, and processes.
An excellent opportunity awaits for this renewable contract. Interview times booked and full job specification to review... If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.
We also have a broad variety of other Biometric specific vacancies available in the UK and throughout Europe. Inclusive of SAS programming, Statistical, Clinical programming, Data Management functions, Regulatory Affairs, Clinical Research, QA, Compliance & Validation.
For a confidential consultation call James Carrera on 0044 (0) 207 255 6665
or email your CV to james.carrera@1st-pharmapeople.com
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