SAS Programmer

Position Summary

The Statistical Programmer will work with the Clinical Development and Operations group and support data analysis and reporting for clinical trials and regulatory submissions. He/She leads statistical programming activities internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to the clinical project team counterparts and estimating resource needs. He/she accomplishes tasks and communicates issues, as necessary, to senior management. This includes communication and quality oversight of vendors. He/she is comfortable representing the Statistical Programming perspective to the clinical project team and is often the sole functional representative. He/she develops and implements standard programming practices while also ensuring that they are employed across a study. He/she also contributes to improve the tools and processes for Statistical Programming.

ESSENTIAL FUNCTIONS

Core Responsibilities

• Leads, coordinates, and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight.

• Authors CDISC ADaM (analysis data model) analysis dataset specifications and SDTM specifications, including the identification of potential data issues or areas of critical data examination. Works with Biostatistics on defining and documenting programming endpoint algorithms

• Manage and contribute to the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewers guides, annotated CRF, define and XPTs), works with SMEs in Statistical Programming to ensure compliance to ESUB standards

• Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with Business Process and Quality Management.

• Serves as the Statistical Programming Lead to achieve milestones for a study; evaluates task objectives, collaborates with Data Management and/or manager on issues or resource needs.

• Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with SMEs from Data Standards and the data strategy plan.

• Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leadership Qualifications:  

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes: 

• Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures. 

• Being honest and treating people with respect and courtesy. 

• Constantly striving to make a great place to work, and a company respected for the quality of its people and products. 

• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred.

• 8 years relevant work experience within an organization with a focus on analysis and data management, 8 years SAS Base programming with 8 years using SAS STAT, GRAPH and MACRO, 8 years relevant industry experience, 8 years clinical trial experience, 5 years clinical database experience, CDISC and/or submissions experience.

• Knowledge of drug development process and clinical trials.

• Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.

• Comprehensive knowledge of the CDISC standards and concepts, and the current best practice in the industry. 

• Strong analytical skills and Attention to detail including proven ability to manage some competing priorities.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

Salary : $90,000 - $115,000