Principal Statistical Programmer – Pharma

Our growing Biometrics Group seeks a Principal Statistical Programmer to provide programming support for the statistical analysis and database management. Will assist with strategies, policies, and standards; and as needed, will run the statistical tables, listings and figures.

RESPONSIBILITIES

1. Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.
2. Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
3. Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents and reviewer’s guides per CDISC and FDA specifications and guidelines using standard tools and templates.
4. Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages and support responses to health authority information requests.
5. Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
6. Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
7. Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
8. Accountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.
9. Manage all aspects of Statistical Programming deliverables for multiple studies/projects.
10. Support in development and review of global standards, templates, processes, SOPs and Work Instructions.
11. Partner with cross functional groups on timelines, vendor selection and CRO oversight.

REQUIREMENTS

1. BS or MS in Computer Science or Biostatistics.
2. Minimum of 6 years of industry experience in Statistical Programming to include oversight of CRO deliverables.
3. Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
4. Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
5. Extensive experience of data integration.
6. Must possess the ability to work in a team environment.
7. Excellent written, verbal and interpersonal communication skills.
8. Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
9. Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.

PREFERRED SKILLS & EXPERIENCE

1. Good knowledge of 21CFR11 and GCP.
2. Good knowledge of Drug development process and Biostatistics.
3. Current knowledge in technologies and tools related to Statistical programming or Biostatistics.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

EEO

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.