Assoc Dir, Statistical Programming (DG)

Date Posted: 10/18/2023

Associate Director, Statistical Programming
Southern, CA (Hybrid - 3 days a week onsite)
AIP (bonus) – 25%, LTI – 2023 face value $65,000 - Base $185-195K

SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations. Standards: Oversees effort to determine and implement global company standards related to output design and programming conventions. Responsible for monitoring regulatory guidance and industry best practices. Case report forms and database definitions: Provides strategic guidance on the development of CRFs and database designs. Provides in-depth critical review of global standards related to CRF designs and database designs. Derivation Programming, Submission Data Sets and Programs: Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications. Oversees effort to determine and implement global company standards related to derive datasets and submissions. Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas. Demonstrates an understanding of drug development principles. Anticipates potential problems within and across projects and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels. Participates in and is viewed as a key contributor to cross functional initiatives. Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists, and non-scientists. Effectively presents information through planning and execution of meetings and presentations. Training and Mentoring: Provides appropriate background and motivation to staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures that self and staff are compliant with training requirements. Effectively mentors statistical programming staff regarding functional operations. Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects. Works collaboratively with the statistical programming management team to assess project resource requirements versus current staff. Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views. Provide all performance management activities for 4-10 statistical programmers.

REQUIREMENTS:
MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience. OR BS in Statistics, Computer Science, or a related field with 12+ years of relevant experience. High degree of technical competence and communication ability, both oral and written. Highly competent in SAS programming and Macro development. Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and relevant regulatory requirements. A minimum of 2 years management experience required.

Please contact Darren Gutowski at dgutowski@clarkdavis.com