Job Title: Lead Biostatistician
Location: Waltham, MA
Duration: 12 months
Note: PK Experience Needed
Job Description:
- Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells
- Performs quality control (source code review, double-programming and log review) of SAS programs
- Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications
- Prepares specifications for CDISC and other analysis data sets
- Assists Data Management with SAS programming needs
- Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study tea
Requirements:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
- 8+ years of experience in SAS programming within the area of clinical trials
- Prior experience using computerized information systems preferred
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment
- Demonstrated working knowledge of basic clinical trial design and analysis principles
- Working knowledge of CDISC standards and application of these standards to projects
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
- Excellent team player, collaborative and able to build an effective team
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Is customer service focused in approach to work both internally and externally
- Maintains a positive, results orientated work environment.
- Ability to build client confidence and achieving high levels of customer satisfaction
- Attention to detail and ability to independently work on stand-alone Biostatistical projects with general supervision
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