Senior StatisticianPosted: November 3, 2009
ATS is an information technologies consulting company providing services to Fortune 500 companies nationwide. ATS specializes in providing full-service staffing solutions by providing technical and business personnel through staff supplementation and project engagements. The company has extensive contacts within its Fortune 500 client base and is able to access a large pool of talented and responsive professionals with proven records of accomplishment in both the technical and business fields.
We are currently seeking a Senior Statistician (with an emphasis on Biometrics, Medical Affairs, and/or Virology). This position will serve as a dedicated statistician to support statistical activities including but not limited to providing statistical advice and support for Research and Development virology franchise global medical affairs. The primary focus is to provide statistical (including programming) support for protocol and SAP-specified and exploratory data analyses (EDA, data mining) for R&D and MAF studies. Secondary emphasis is to contribute to peer-reviewed medical publications and the development of company policies and procedures relating to statistical analyses.
Specific Tasks
1. Works directly with senior director of medical affairs virology Biometrics, statisticians, virologists, and representatives from other departments to lead the EDA activities. This includes coordinating meetings, managing EDA requests and timelines, developing new questions/ideas based on existing or future data, designing analysis strategies, executing analyses, presenting results/findings to internal and external audients, and serving as lead co-author/presenter of applied medical/statistical posters, presentations, and manuscripts
2. Contributes to power calculation or re-calibration for new studies via various approaches including data simulation, numerical solution, and closed form calculations based on methodologies available in the literature
3. Develops statistical programming solutions such as bootstrapping for inference of non-standard statistical questions where no closed form solution exists and/or the solution is difficult to program
4. Works with data managers and clinical programmers to design master analysis database for key baseline, safety, and efficacy parameters
5. Reviews and provides input to statistical analysis plans, including statistical analysis plans from R&D and MAF studies.
6. Provides statistical support to R&D and MAF studies including, but not limited to developing analysis specifications, generating programmed statistical outputs in the form of tables, listings, and figures, and quality control via independent programming of outputs from external contractors and/or CROs
7. Ensures that statistical analyses are conducted in compliance with relevant SOPs, policies, and guidelines and maintains consistency, efficiency, and high quality of statistical methodology within the virology therapeutic area
8. Develops and contributes to company SOPs relating to statistical analysis
9. Ensures the timely production and quality control of statistical deliverables according to project plans and publication deadlines for assigned studies and projects
10. Keeps abreast of new developments in statistical methodology, related guidelines and regulations
Development and Improvement of Departmental Procedures and Processes
Contribute to the creation, review and implementation of new SOPs, Work Instructions, guidelines, processes, documents and other tools to build an efficient Virology Global Medical Affairs Biometrics team and ensure flawless support
1. Job Requirements
Qualifications
• PhD in Biostatistics plus 4 years relevant work experience, 2 in virology area, or equivalents
Experience, Skills, and Knowledge
1. Proven ability to effectively prioritize and manage multiple projects
2. Excellent interpersonal, problem-solving, and organizational skills
3. Excellent written and verbal communication skills
4. Ability to perform independent SAS programming/analytics (75%)
5. Excellent knowledge of probability, statistical interference, applied statistics and the design and analysis of clinical trials
6. Excellent hands-on knowledge of SAS/S-Plus programming and clinical databases
7. Working knowledge of clinical data analysis and reporting process as it pertains to pharmaceutical development, particularly in late-phase and post-marketing such as publications, data exploratory data analysis, ad hoc reporting, etc…
8. Good understanding of Virology with emphasis in HIV/AIDS/Hepatitis
9. Excellent working knowledge of English, both spoken and written
10. Knowledge of applicable guidelines regarding statistical design and analysis of clinical trials (ICH, etc…) and drug development guidelines (GCP, etc…)
2. Required Certifications/Regular Training
• ICH/GCP
• 3 years antivirals experience with 1 years HIV experience
• Submission Standards
• SAS programming
• Statistical scientific developments
ATS offers health coverage, 401K participation, Long Term Disability and Life Insurance. Please refer to job code 09-00032 when responding to this ad.
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