Description:

Position Summary:

Works closely with other programmers, biostatisticians, and clinical data managers with a leading role in the collection, analysis, and reporting of clinical data for phase I-IV clinical development programs.

Primary Responsibilities:

• Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.

• Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.

• Following specifications, develops algorithms and writes programs to create datasets.

• Produces data listings, summary tables and graphs using SAS software.

• Independently checks data listings, summary tables and graphs.

• Imports and exports SAS data.

• Assists data management group in performing data edit checks.

• Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.

• Plays an active role in taking project solutions and generalizing them for the Biostatistics group.

• Interacts with the project statistician and guides other programmers participating on a project team.

Skills:

Sas programming, CDISC

Top Skills Details:

Sas programming,CDISC

Additional Skills & Qualifications:

Education/Experience/Skills:

Bachelor’s degree in a statistics, computer science, or a similar quantitative field; an equivalent combination of relevant education and applicable job experience may be considered. Experience in programming with the Statistical Analysis System (SAS) beyond classroom work is required.

Minimum of 5 years’ experience in clinical statistical programming within pharmaceutical or related industry (biotechnology, medical device, Clinical Research Organization (CRO)). SAS Certified Base and/or Advance Programmer experience is preferred.

Must possess:

• Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS.

• Experience with SDTM and ADaM industry data standards.

• Exposure to statistical graphics software.

• Good communication skills and attention to detail are crucial.

• Proven ability to handle multiple tasks.

• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

• Skilled at promoting team cooperation and a commitment to team success.

• Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

Experience Level:

Intermediate Leve

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

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