Manager, Statistical Programming

Roivant; New York (NY); Hybrid; USD 130,000 - 197,000; Full time

Job summary

An established industry player is seeking a Manager of Statistical Programming to lead and oversee statistical programming tasks for clinical studies. This role involves collaborating with cross-functional teams, ensuring compliance with regulatory standards, and providing expert programming support for clinical trials. The ideal candidate will possess extensive experience in SAS programming and CDISC standards, making significant contributions to oncology and rare disease studies. Join a forward-thinking company that values innovation and offers a dynamic work environment with opportunities for professional growth.

Qualifications

• 5+ years of SAS programming experience in CRO or pharmaceutical industry.
• Experience with CDISC standards including SDTM and ADaM.
• Lead statistical programmer for development assets.

Responsibilities

• Oversee statistical programming tasks for clinical studies.
• Generate and validate SDTM domains and ADaM datasets.
• Collaborate with cross-functional teams on clinical programs.

Skills

SAS Programming

CDISC Standards

Statistical Analysis

Data Management

Education

Master’s in Statistics

Bachelor’s in Statistics

Tools

SAS/BASE

SAS/STAT

SAS/GRAPH

SAS/ODS

Job description

Roivant Sciences, Inc., 151 West 42nd Street, 15th Floor, New York, NY 10036, United States

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:

• 5 years of experience with SAS programming skills.
• 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.
• 5 years of experience in SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS Macro languages.
• 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:

• 7 years of experience with SAS programming skills.
• 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.
• 7 years of experience in SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS Macro languages.
• 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 [e-mail]

Roivant Sciences is an Equal Opportunity Employer.

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