Description

 

Cytel are seeking a Contract Senior Statistician to join our high growth global Clinical Research Services business unit. The Senior Statistician will be responsible for all aspects of statistical project support to clinical studies and volunteer trials and will independently and proactively ensure project statistical support needs are fully met and study designs and analyses are statistically valid and meet the recognised international standards. 

You will expertly and independently provide consultancy advice on study design, write protocol statistical considerations sections and report and disseminate study results. You will do this across a broad range of applications, to establish full project involvement and influence, and to further develop statistical and software applications skills.

In this role, you will be responsible to:

• Expert and Statistics Support:
• Lead project statistical support ensuring that needs are fully met by expert and timely statistical consultancy and support.
• Input into clinical research programmes and study protocols. Independently provide study design consultancy, decide on statistical analysis methodology, specifying the protocol statistical considerations section including the analysis plan
• Review statistical considerations sections, results sheets and clinical study reports
• Collaborate on research and development projects advising on study design, analysing and reporting results.
• Specify table templates, write analysis dataset specifications, analyse data, write clinical study reports, results sheets and data on file reports, disseminate study results with study teams and brand managers, write manuscript results sections for publication and critique competitor promotional material
• Develop, test and run SAS programs for analysis datasets, report tables, graphics and statistical analysis, liaising with statistical programmers as appropriate.
• Deliver training and awareness sessions to research and clinical research staff at all levels
• Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.

 

Systems Compliance and Self Development:

• Identify and lead systems and process development to improve the efficiency and quality of work within the statistics function under the management of the Statistics Manager
• Further develop knowledge of design consultancy and analysis methodology, and statistical software packages (e.g. SAS and Proc Statxact, MlwiN, Nquery, PEST, EAST, Quality Analyst).
• Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
• To perform all activities in compliance with relevant GCP, GMP and Quality Systems standards and specifically with FDA Quality System Regulation (including 21CFR Part 11), EN46000 and ISO 13485.  Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations.
• To ensure full commercial value is realised from the clinical trial evidence through promotional material and publications in liaison with the CRAs/CPMs and commercial

  

Qualifications and Experience 

You will have a PhD degree in Statistics or Biostatistics or related field with some applied statistics training relevant to the clinical trials or health research environment, and one (1) year of relevant work experience or a Master’s degree in Statistics or Biostatistics or a related health science field and at least 5 years of statistical experience in the clinical trials or health research environment.

Additionally, we require excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials. 

Compensation & Benefits
We offer competitive salary-based package, bonus, comprehensive medical health insurance and pension.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

 

Who We Are

The clinical development of drugs and devices is crucial for human welfare. Our mission is to improve success rates in this endeavor.

We do this by improving the design and implementation of clinical trials through the innovative application of statistical science, operations research, and information technology.

 

What We Do

We provide unrivalled biostatistics and operations research knowledge to our customers. Our knowledge is available in the form of both software and services. This knowledge, supported by our trial implementation capabilities, is what makes us different. We are leaders in the design and implementation of adaptive clinical trials.