Provide leadership, oversight, and management of the Statistical Programming Group. Plan, organize, manage, and carry out large-scale programming projects, including internally supported studies. Support the inferential analysis of key safety and efficacy endpoints from clinical trials. Develop and maintain a standardized programming environment, plan program development around anticipated needs, and manage outside as well as internal resources in statistical programming. Primary responsibilities include group leadership, process development (programming library, guidelines, standard operating procedures) and project team leadership of outside and internal teams established to generate statistical analyses, tables, figures, and listings intended for regulatory submission. Essential Functions 1. Direct and coordinate the activities of the Statistical Programming Group. Provide direct-line management of other management staff in the Statistical Programming Group, as well as oversee the work of internal and external statistical programmers who support the project teams. – 50%
2. Oversee creation of tables, figures, and listings for internally supported studies and ad hoc analyses. – 10%
3. Oversee validation of tables, figures, and listings produced by external vendors and internal staff, as appropriate. – 20%
4. Provide leadership for NDA preparation and support activities, as needed. – 10%
5. Set the strategic direction for the programming environment, including selection, maintenance, and upgrades for the programming software, as needed. – 5%
6. Organize training for internal and external staff, as needed. – 5% Minimum education requirements Bachelors Experience required 10+ Years Knowledge & skills (general and technical) Education level and/or relevant experience(s):
Bachelor or higher level degree in Computer Science, Biostatistics, Statistics, or a related field.
Management experience, experience with regulatory submissions, electronic submissions (particularly eCTD), relational databases, and project and proposal management experience.
At least 10 years experience (preferably in the pharmaceutical industry or medical research) or equivalent, depending on educational level.
Knowledge and skills (general and technical):
Must be able to supervise statistical programming staff, as well as work cooperatively with project and protocol team members, project management, medical directors and other scientific staff, and outside vendors.
SAS® experience is a requirement.
Experience with SAS® macros is desirable.
Other requirements (licenses, certifications, specialized training, and physical or mental abilities required):
- The individual in this position should have strong management skills and technical depth, in concert with breadth of experience.
- SAS® Certification is desirable.
- CDISC training/experience is desirable.
- Experience with electronic submission formats such as eCTD 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 Sunovion 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 personal computer for extended periods of time.