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About Company:

Global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

Must Haves:

• Development of SDTM

• Development of ADaM

• Development of Tables, Listings and Figures

• Development of Define.xmls

Description:

Provides advanced computer programming support for some or all of the following activities: creation and maintenance of programs used for data entry, data management, data validation, statistical report generation, and program validation. Assists Data Management and Biostatistics with developing tools and techniques for improving process efficiencies. Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget. Acts as Programming Lead or Biostats Project Lead on projects. Acts in a consult or mentor role for all junior staff as needed on programming and/or leadership topics. Input into resource allocation. Reviews and makes recommendations for process development and improvement. Provides input to the bidding process.

• Understands and follows department's working practice documents and SOPs, and contribute to their development as needed.

• Understands and follows appropriate corporate SOPs.

• Works directly with project team leaders and client representatives to assess and develop project goals and timelines.

• Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases.

• Independently creates, executes, maintains, and validates programs that generate listings, tables and figures using SAS.

• Supervises and performs other programming tasks as necessary to support Clinical Data Management and Biostatistics.

• Assesses and ensures the validity of all program output.

• Serves as a project lead and oversees work of other programmers on team.

• Manages assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.

• Assumes leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed.

• Documents all work; manages assignments to meet timelines and produces high quality deliverables.

• Demonstrates a good understanding of the role of the programmer in the overall process.

• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.

• Works efficiently and effectively with little direct supervision.

• Supervises, trains and mentors other programmers.

• Participates in developing SOPs and working practice documents.

• Provide general infrastructure support to the Biostatistics Department. Examples include presentation / teaching at Department meetings, contributing to other general department documents or policies, and assisting with Biostatistics web page development.

• Acts as Biostats project lead across the most challenging and complex projects.

• Mentors and in some cases supervises statistical programmers.

• Acts in a consultancy basis for entire department. Inputs into resource allocation.

• Provides issue escalation for lower level programmers.

• Reviews and makes recommendations for process development and improvement.

• Inputs into bidding process and assists on biostat metrics.

Education and Experience:

MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and a minimum of five (5) + years experience, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7+ years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

• Proficient in one or more programming languages

• Ability to train, mentor and supervise others

• Understanding of relational data base structure and experience working with complex data systems

• Demonstrated strong attention to detail

• Demonstrated leadership ability and ability to work on a multi-disciplinary project team

• Excellent problem solving and innovative skills

• Excellent written and verbal communications skills

• Ability to independently and effectively organize and manage multiple assignments with challenging timelines

• Ability to adapt and adjust to changing priorities

• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others

• Demonstrated leadership, initiative and motivation

• Capable of acting as project lead across the most challenging and complex projects

• Demonstrated ability to mentor and in some cases supervising statistical programmers

• Able to identify solutions and options for lower level programmers

• Demonstrated ability to make recommendations for process development and improvement

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.