Senior Statistical Programmer (FSP), Georgia, Poland, Serbia, Hungary

Parexel•Georgia-Remote, GA

5d•Remote

About The Position

Parexel is currently seeking a Senior Statistical Programmer to join us in either Georgia, Serbia, Poland or Hungary, dedicated to a single sponsor. The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data.

Requirements

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development.
Proficiency in SAS is required.
Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational database.
Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
Good understanding of regulatory, industry, and technology standards and requirements.
Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
Applicants must be authorized to work in Georgia/Poland /Serbia/Hungary. We are unable to sponsor or take over sponsorship of an employment Visa.

Nice To Haves

Experience with R would be a strong asset.

Responsibilities

Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs.
Provides programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
Support the electronic submission preparation and review.
Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities.
Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers.
Provides leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
Identifies opportunities for increased efficiency and consistency within team and our interactions with strategic vendors.
Independently leads and / or performs programming assignments with minimal supervision.
Support improvement initiatives.