The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Principal Statistical Programmer in for a remote opportunity

Role Description

Participate in the oversight, creation, maintenance and finalization of clinical study datasets/TFL for Ipsen development programs, and ensure all clinical datasets perform the analysis defined by SAP and meet the standards required for regulatory submissions for all INDs and NDAs/MAAs Main responsibilities / job expectations
• Responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinicaltrial data in order to produce quality and timely deliverables.
• Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/ISE).
• Creation/QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
• Interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements.
• Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents.
• Participate in operations meetings and address issues that may influence statistical programming and data management.
• Work with CRO statisticians, statistical programmers and review/QC their work/deliveries.

Skills & Requirements

• Proficiency in statistical programming package(s), SAS is required; R or other packages are desired.
• Familiar with Global Clinical Data Interchange Standards Consortium (CDISC).
• Understand clinical data flow. Experience in NDA submission is desired.
• Experience in SDTM and/or ADaM specification and programming.
• Experience in TFL programming.
• Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
• Good computer literacy
• Bachlor’s degree or higher in Statistics, Mathematics, or Scientific Discipline
Experience:
• 5+ years’ programming experience in pharmaceutical/biotech/CRO environment in drug discovery/clinical trials / drug development
• Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.
Languages:
• Strong verbal and written communication skills (English) with the ability to communicate effectively at different levels of the organization

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

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Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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