Associate Director, Statistical Programming
The Statistical Programming Associate Director will be responsible for multiple therapeutic areas or therapeutic indications leadership of a statistical programming group that supports multiple drug development programs.
The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process. The incumbent will assist the head of Statistical Programming to develop, recommend, and implement standard procedures, measures of performance, and training programs. Serve as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines. Provide leadership to the company in the area of technical expertise.
Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
- Manage a group of statistical analysts, including managers and analysts
- Act as principle analyst to provide statistical programming service to multiple therapeutic areas
- Provide review and supervision of the departmental staff in a manner that promotes problem solving, career development, and motivation
- Develop, revise, and maintain Standard Operating Procedures and Work Instructions
- Support the Head of Statistical Programming to achieve the company’s goals
- Develop staff for current and future positions
- Stay abreast of current regulatory environment focusing on submission standards
- Provide input in the selection of CROs, manage CRO programming activities for complex studies
- Lead task forces to develop complex, technical solutions for projects or business needs
- Independently bring technical solutions to the Statistical Programming department
- Develop and maintain good communications and working relationships with internal/external functions
- Ensure that the company business needs and partner organizations are satisfied within agreed-upon timelines with respect to statistical programming activities and the exchange of data sets for clinical studies
- Lead the effort of programming process improvement
- Assist in validating software products used by the Statistical Programming department
- A B.S.(or higher) in Statistics, Computer Science or other closely related field to programming with minimum 12 years of relevant pharmaceutical/biotech industry experience.
- At least 8 years of demonstrated leadership experience including minimum 3 years in people management; career progression.
- Direct experience in leading programming in supporting NDA, BLA and EMEA filings.
- Expert experience using industry standards such as CDASH, SDTM, and ADaM.
- Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS/GRAPH.
- Experience in development and implementation of statistical programming standards and procedures is required; knowledge of software systems development is required.
- In depth understanding of clinical trial principles and regulatory requirements.
- Expert knowledge of industry data standards.
- Demonstrated ability to manage and lead projects for Statistical Programming and managing programmer.
- Effective verbal and written communication and strong interpersonal skills.
- Strong project management skills; flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks. Must work well within a dynamic, interdisciplinary, small company environment requiring multi-tasking and changing priorities.
- Dynamic self-starter; agile learner; strategic and creative thinker.
- Demonstrated strong problem solving and risk-mitigation skills.
This position does not have direct reports currently and is expected that the Manager will be highly effective at managing and coordinating statistical programming efforts in a therapeutic area.