Manager, Statistical Programming

Roivant Sciences has an opening for a Manager, Statistical Programming in New York, NY.

Responsible for day-to-day statistical programming tasks for all assigned studies conducted by Roivant Sciences and/or subsidiaries, including oversight of CRO statistical programming activities and collaborate with other functional areas such as data management and biostatistics. Provide expert-level hands-on programming support to all clinical studies and regulatory submissions. Work closely with cross-functional study team members on multiple clinical development programs in oncology/hematology, rare disease, or anti-infectious disease studies. Day to day job duties include:

• Responsible for creating/reviewing SDTM/ADaM mapping specifications.
• Generate and/or validate SDTM domains, ADaM datasets, reviewer's guide, and define.xml files.
• Generate and/or validate TLFs to support the statistical analysis of clinical trial, regulatory submissions, and publications such as CSR, DSUR, IB, publications, IR, etc.
• Lead programming efforts to support exploratory/ad-hoc analysis of clinical trial data.
• Work with data management to develop SAS programs to support study data review.
• Review study documents such as CRF, DMP, SAP, etc.
• Apply SAS programming knowledge to solve problems related to non-routine situations.
• Work collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas; understand and perform in accordance with regulatory standards and drug development principles.
• Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.

The position requires a Master’s degree in Statistics, Mathematics, Data Analytics or Computer Science, a related field or foreign equivalent, plus 5 years of experience in any occupation in which statistical programming experience within the CRO, biotechnology, or pharmaceutical industry was gained. Experience must include:

1. 5 years of experience with SAS programming skills.
2. 5 years of professional experience in CDISC, including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
3. 5 years of experience in SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS Macro languages.
4. Demonstrated experience acting as the lead statistical programmer for at least one (1) development asset.

In lieu of a Master’s degree, employer will accept a Bachelor’s degree in Statistics, Mathematics, Data Analytics, or Computer Science, a related field or foreign equivalent, followed by 7 years of progressively responsible experience in any occupation in which statistical programming experience within the biotechnology or pharmaceutical industry was gained. Experience must include:

1. 7 years of experience with SAS programming skills.
2. 7 years of professional experience in CDISC, including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
3. 7 years of experience in SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS Macro languages.
4. Demonstrated experience acting as the lead statistical programmer for at least one (1) development asset.

Full-time telecommuting permitted. Individual must travel to Roivant HQ in New York, NY at least 4x a year.

Wage Range: $130,688 - $196,032/year

Resumes to ken.brown@roivant.com

Roivant Sciences is an Equal Opportunity Employer.