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Clinical Statistical Programmer - New Haven, CT
- Note: This employment opportunity has expired and is no longer available. It has been retained for historical interest only.
- For current listings see Employment opportunities.
COMPANY: Achillion Pharmaceuticals, Inc.
POSITION: Clinical Statistical Programmer
LOCATION: New Haven, CT
This position will be responsible for applying programming techniques for the development of statistical deliverables reporting on clinical trials data in support of regulatory submissions and publications
- Collaborates with project statistician to develop statistical deliverables, including analysis plans, tables, listings and graphs (TLFs), datasets, IVRS specifications
- Develops standard reporting tools, including SAS® programs, to provide study TLFs and datasets
- Works closely with Clinical Operations to ensure the statistical and data management aspects of clinical studies will meet project timelines
- Monitors CRO activities regarding statistical programming deliverables and reviews CRO deliverables as necessary
- Collaborates with data management to provide solutions on clinical data issues
- Collaborates on the design and review of database structures and reviews data management plans (including review of eCRFs) to ensure compliance with Industry and regulatory standards
- Develops data transfer specifications for external data transfers and interacts with external data vendors (e.g., eCRF, laboratory, PK) to ensure successful data transfers
- Participates in the development of submission datasets
- Verifies SAS datasets, including clinical data from external sources, with Company dataset standards; troubleshoots problems with clinical datasets
- Evaluates results and assists in the preparation and distribution of reports to the project team members
- Assist in preparation of Clinical and/or Regulatory submissions (INDs, IND Annual Reports, Safety Updates, NDAs, CTDs), Investigator Brochure updates and protocol writing.
- Other duties as assigned.
Competencies: Self-motivation, flexibility, ability to establish and manage multiple priorities and multi-task effectively to meet stated internal and external commitments. Must exercise sound judgment and take initiative, be able to work independently with minimal supervision while producing accurate and timely work. Work with a high attention to detail. Excellent written and verbal communications skills mandatory. Ability to present study data and results (clinical and non-clinical) to internal and external audiences.
Knowledge of: Commanding understanding of the clinical operations, data management, and biometrics roles within a clinical trial setting. Working knowledge of CDISC submission data principles, including SDTM, ADaM. Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).
Education: BS, MS Degree preferred, in mathematics, statistics, or related analytic field. Other degrees with appropriate combination of education and relevant experience.
Experience: Minimum 5 years of SAS programming experience within the pharmaceutical and/or biotech industry. Intermediate to advanced SAS programming techniques, including strong SAS graph skills are necessary. Experience including TLF programming, and PK TLF programming, required. Prior experience interacting with, or monitoring of, CROs preferred. Experience with incorporating outsourced deliverables into in-house database structures. NDA Submission experience, including ISS programming and submission dataset development, within current industry data submission standards.
Achillion Pharmaceuticals, Inc
300 George Street
New Haven, CT 06511
Web site: http://www.achillion.com/careers