Senior Manager, Statistical Programming 6559BR Marlborough, MA
– Provide statistical programming support to clinical trials for regulatory submissions and various publications, posters, … etc.
– Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials.
– Develop and maintain the infrastructure for project files of SAS datasets and SAS programs.
1. Provide statistical programming support to clinical trials for regulatory submissions and publications, and ad hoc or post hoc analyses. Generate analysis data sets, listings, tables and figures, as well as supporting documentation (i.e. define.xml) for clinical studies.
2. Function as lead programmer on single or multi-protocol projects, and participate in project team
meetings. Assume protocol level responsibilities in statistical programming. Review protocol and SAP, write/review analysis data specifications, etc. Interact with Statisticians, Clinical Data Programmers, Data Managers, Clinical Operations personnel and project manager to ensure the timeline and quality of analysis data and reporting.
3. Independently validate SAS data sets and outputs from CROs or other programmers. Prepare validation documentation.
4. Develop and maintain SAS programming infrastructure, macros and standards. Adhere to the company's and departmental SOPs, Working Instructions and Standards. Participate in the company's development and implementation of global analysis data standards, output formats, standard SAS programs, etc.
Knowledge & Skills:
- Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO.
- Extensive experience in creating/reviewing/validating analysis datasets, tables, figures, listings, and documentation necessary to support electronic submissions and publications.
- Demonstrated NDA, sNDA submissions and ISS/ISE experience.
- Working familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISC SDTM and ADaM).
- Strong communication skills both oral and written.
- Strong organizational and time management skills and the ability to handle multiple assignments effectively and deal with ad hoc requests.
- Ability to proactively plan so as to minimize potential re-work, as well as effectively and efficiently problem solve.
- 5-7 years programming experience in the pharmaceutical industry or equivalent experience
- Education in statistics is highly desirable
- SAS® Certification is desirable.
- CDISC training/experience is desirable.
- Experience creating CDISC ADaM datasets and using SDTM datasets is highly desirable
- Experience with creation and review of CDISC-formatted electronic submission deliverables is desirable