Director Statistical Programming
Statistics & Data Corporation (SDC) a specialized contract research organization (CRO) headquartered in Arizona delivering top-tier clinical trial services to pharmaceutical biologic and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise as well as the technology they need to be successful in their clinical trials.
Job Summary
Leads Statistical Programming department and maintains the quality integrity and customer
centric focus across the operational services. Provides input to company strategic direction in support of
company goals. Oversee multiple teams of statistical programmers; manage statistical programming timelines and resources across the department; lead personal development training and performance reviews. Manage statistical programming resources and ensure on time quality deliverables for team(s). Provide statistical programming support to clinical trials by producing statistical analyses including generating SDTM datasets ADaM datasets and tables listings and figures for clinical trials. Develop and maintain the infrastructure for project files of SAS datasets SAS code and supporting files. Support Data Management in dataset creation/transfers integrity checks and quality audits. Support process improvements and standardization within the statistical programming and biostatistics workflow. Leads key corporate and department initiatives.
Primary Responsibilities
Manage all statistical programming activities involved in the conduct and analysis of data from clinical trials conducted by SDC.
Supervise staff (primarily Manager levels) to include assignment of work allocation of resources and management of timelines to ensure contractual obligations and objectives are met.
Serve as a consultant with internal and external cross-functional areas regarding operations and processes
Recommend and optimize statistical programming processes and tools
Lead the design/development of SAS macros and other utilities to expedite statistical programming activities
Function in an oversight role of Senior Statistical Programmers on clinical trial(s) as required:
- Create mapping and programming/validation for SDTM and ADaM datasets
- Create and associated documents
- Generate tables listings and figures per the protocol statistical analysis plan and/or approved client requests
- Participate in statistical program validation and quality control activities
- Develop code for complex data checks and data listings to assist Data Management activities
Interact with other departments such as Biostatistics Business Operations Project Management Change Management Technology Solutions and Data Management to ensure a high level of client satisfaction through successful execution of projects
Ensure all programming activities and processes performed are conducted according to SDCs standard procedures and/or sponsor requirements
Develops Department KPls metrics and reports to analyze data for projects and communicate results across the organization and to Sponsors (as appropriate)
Proactively identify project quality scope budget or partner/client issues and manage escalation as appropriate to ensure resolution
Assists in determining policy and strategic planning pertaining to future Statistical Programming direction
Identify and support key corporate initiatives
Continue to enhance operational models in support of global programming team
Develops and adheres to department budget and monitors key financial indicators (Revenue
Expenses FTE and DLU) according to corporate goals within Statistical Programming
Develop and optimize efficient work processes and standards and train on these processes and standards
Adhere to and enhance all aspects of the SDCs quality system; comply with SDCs data integrity & business ethics requirements
Perform other related duties incidental to the work described herein
Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
Good leadership organizational and time management skills with the ability to multi-task
Skilled in analytical evaluation organization delegation flexible team management negotiating and resource management skills
Solid management background with a track record of successfully leading a team of statistical programmers
Experience with mentoring and training junior statistical programmers
Excellent knowledge of statistical programming processes in clinical trials
Experience manipulating and analyzing SAS data with proficiency in SAS/Base SAS/Stat SAS Macros and SAS/Graph
Expertise with CDISC standards and implementation of those standards primarily SDTM ADaM and
Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11
Ability to identify issues present problems and solutions and execute solutions
Focus on quality and developing/implementing quality systems for statistical programming
Strong interpersonal communication and presentation skills
Education or Equivalent Experience
Bachelors degree in computer science statistics or other related scientific field and more than ten years of relevant professional experience with skill in a management or leadership role; or an equivalent combination of relevant education and/or experience. Masters degree is preferred.
Benefits
Why SDC
SDC is a team of diversified professionals who deliver exceptional Biometric Services Consulting and Technology Solutions to pharmaceutical biologic and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings focused services area specialists efficient project timelines optimal technology solutions and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay generous time off attainable career advances and positive work/life balance we are able to attract some of the most talented people in the industry.
We are committed to developing our employees. We recognize achievements provide growth opportunities and career advancement offer a flexible work schedule engaging work culture and employee benefits.
We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy Integrity Engagement Innovation Ownership and Commitment.
We strive to provide a place of belonging to our employees with fun and engaging activities from SDCs culture club.
We are constantly growing and innovating to support our client and employee needs. Global in nature we bring diverse perspectives enabling our growth in this ever-evolving industry.
With a proven track record SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team!
#LI-Hybrid
Required Skills:
Required Skills Good leadership organizational and time management skills with the ability to multi-task Skilled in analytical evaluation organization delegation flexible team management negotiating and resource management skills Solid management background with a track record of successfully leading a team of statistical programmers Experience with mentoring and training junior statistical programmers Excellent knowledge of statistical programming processes in clinical trials Experience manipulating and analyzing SAS data with proficiency in SAS/Base SAS/Stat SAS Macros and SAS/Graph Expertise with CDISC standards and implementation of those standards primarily SDTM ADaM and Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11 Ability to identify issues present problems and solutions and execute solutions Focus on quality and developing/implementing quality systems for statistical programming Strong interpersonal communication and presentation skills Education or Equivalent Experience Bachelors degree in computer science statistics or other related scientific field and more than ten years of relevant professional experience with skill in a management or leadership role; or an equivalent combination of relevant education and/or experience. Masters degree is preferred.