At Roivant, we are passionate about discovering and developing new drugs to impact patients’ lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world’s leading tech-enabled pharmaceutical company.
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.
The Senior Manager, Statistical Programming will be 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. The Senior Manager of Statistical Programming provides an expert-level hands-on programming support to all clinical studies and regulatory submissions.
The Senior Manager, Statistical Programming will report to the Head of Statistical Programming and will work closely with cross-functional study team members on multiple clinical development programs in oncology/hematology, rare disease or anti-infectious disease studies. This position is a remote, work from home opportunity.
- 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.
- Critically review study documents such as CRF, DMP, SAP, etc.
- Proficient in applying 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.
- Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
- Perform other assigned duties as assigned.
- Minimum Bachelor’s Degree in Statistics, Mathematics, or Computer Science.
- Minimum 10 (Master degree) or 12 years (Bachelor degree) of progressive statistical programming experience in CRO, biotech, or pharmaceutical industry.
- Strong hands-on SAS programing skills and working 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.
- Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS Macro languages.
- Must have a high degree of accuracy and attention to detail.
- Strong leadership, interpersonal, organizational, and multi-tasking skills, and ability to work within cross-functional teams.
- Ability to manage multiple initiatives and shifting priorities within a small company environment.
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.