Sas Programmer

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated
**SAS Programmer **who shares our vision of providing clinical research excellence.

Joining Pivotal as a
**SAS Programmer** means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data-driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

**Why Pivotal**

We are passionate and fully committed with medical science while using technology, to make a positive impact

We provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life

We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

**Job overview**:
The Principal SAS Statistical Programmer is responsible for providing leadership and hands-on support in the development and maintenance of the clients’ statistical programming capabilities, which is required to meet regulatory obligations.

The individual will work closely with senior management team in Pivotal to build internal programming tools. This individual, working closely with the study team will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. This individual will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. This individual will collaborate with other departments to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. This individual will participate in department and cross functional technology development and process improvement initiatives. This role reports to the Executive Director Biometrics.

**Main responsibilities and accountabilities**

Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Plans and leads the production and validation efforts for the designed output, this may include oversight of work by CROs.

Collaborates with study teams to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (i.e., SDTM, ADaM, tables, figures, listings, define.xml). Supports the review of related deliverables when provided by CROs.

Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.

Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.

Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.

Works closely with clinical study teams to plan and execute activities to ensure project timelines are met with high quality deliverables.

Additional Tasks:
Collaborates with other Biometrics staff regarding data analysis requests.

Performs additional statistical analyses including but not limited to:

- support responses to regulatory agencies,- generate integrated summary of safety and efficacy,- support publications and presentations,- support planning and reporting of clinical trials via exploratory analyses of available data, replicate CRO and client’s statistician analyses for QC**Requirements**:
BSc in Computer Science, Mathematics, Statistics, or related area with relevant experience

Other degrees and certifications considered if commensurate with related programming experience

At least 8 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.

In-depth understanding of clinical programming and/or statistical programming processes and standards.

In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).

Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-