Position title Senior Manager, Statistical Programming
Department Research & Development
Job type Full-time
Summary of Responsibilities – Provide statistical programming support to mid- and late-stage 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.
Minimum education requirements Bachelors
Experience required 5 – 7 Years
Knowledge & skills (general and technical)
– 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.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required)
• 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
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of 'the company' are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.