12 month remote, renewable contract
The Principal Programmer, Statistical Programming will be responsible for the planning, implementation, and compliance of clinical trial statistical programming activities across multiple studies to produce high quality and timely deliverables for global submissions. In addition to overseeing internal statistical programming activities, the role will provide oversight of external business partners, including technology vendors and CROs, and management of external electronic data sources in order to support drug development processes and global submissions.
- Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
- Serve as the lead programmer in support of NDAs, sNDAs. Provide programming support for the preparation of integrated reports, submissions, and post-submission activities.
- Produce timely, high quality, and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
- Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
- Convert, verify, and integrate multiple sources of incoming data for the creation of analysis datasets.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
- Contribute to the creation, maintenance, and validation of standards for programming tools, outputs, and macros.
- Contribute to the creation, maintenance, and validation of programming tools and macros.
- Influence other functions and represent Statistical Programming technical expertise.
- Collaborate with stake holders and cross functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development.
- Represent as internal team leader who decides best course of action.
- Ensure consistency and adherence to standards within their therapeutic area.
- Implement the filing of study documentation to the standard required according to processes and acceptable for audit.
- Oversee the services provided by CROs.
- Coach and advise junior programmers to identify problems and solutions.
- Contribute to the development and maintenance of a positive team-focused company culture
- Bachelor’s degree or higher
- Minimum of 7 years of experience in leading and supporting statistical programming activities in clinical research for all phases of clinical trials, supporting global trials.
- Experience with regulatory filings, including global submissions
- Extensive knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, FDA/ICH, 21 CFR part 11, and other guidance documents and policies related to clinical trials and operations requirements
- Extensive knowledge of and experience with CDISC standards including SDTM and ADaM dataset specifications and Define-XML
- Ability to lead teams across 1-2 complex projects and assess resource needs
- Excellent SAS Programming skills, with a thorough understanding of clinical data structures.
- Ability to critically analyze information, review reports, communicate outcomes, and prioritize actions
- Excellent computer skills; strong verbal and written communication skills
- Ability to work well in a cross-functional teams as a contributor
- Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships. Excellent computer skills; strong verbal and written communication skills
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