Senior Programmer, Statistical Programming (Remote)

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the 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. 

Our goal is to improve human health by rapidly discovering, developing, and delivering innovative medicines and technologies to all patients. Our success is predicated on attracting and retaining top talent, generating new ideas and promoting an open and collaborative culture.

We embrace diversity across all dimensions and levels of the organization, and we strive to ensure every employee is supported in reaching their full potential. We hire motivated people with diverse backgrounds, identities, experiences and skillsets. We are committed to fostering an inclusive culture where all employees feel valued, respected and empowered to create value for patients.

To learn more about our story and company culture, please visit us at https://roivant.com/

Position Summary

The Senior Programmer, Statistical Programming will be responsible for day-to-day statistical programming tasks for all assigned in-house studies conducted by Roivant Sciences, collaborate with other functional areas such as data management and biostatistics. The Sr. Programmer of Statistical Programming provides proficient hands-on programming support to all clinical studies, regulatory submissions, and ad-hoc requests, as well as exploring alternative programming technology in R and Python.

The Senior Programmer, 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 across diverse therapeutic areas.  This position is a remote, work from home opportunity, and title is up to manager, statistical programming depending on the working experience.  

Responsibilities

• Responsible for creating/reviewing SDTM/ADaM mapping
• Work on SDTM/ADaM datasets and tables/listings/figures creation and/or validation.
• Work on submission package preparation, such as reviewer's guide, xml, data transport files.
• Generate and/or validate TLFs to support the statistical analysis of clinical studies, regulatory submissions, and publications such as CSR, DSUR, IB, publications, IR, etc.
• Support exploratory/ad-hoc analysis of clinical trial data .
• Work with data management to support study data
• Review study documents such as CRF, DMP, SAP,
• Work collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas; understand and perform in accordance with regulatory standards and drug development
• Support new technology development initiatives.
• Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
• Perform other duties as

Skills, Qualifications, and Requirements

• Bachelor’s degree in Statistics, Mathematics, Computer Science, Data Sciences/Engineering, or relevant field Master’s degree preferred.
• 4 - 10 years relevant working experience in CRO, biotech, or pharmaceutical industry.
• Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS Macro
• Other programming skills such as R, Python, VBA and knowledge of OpenAI, ML/NLP are preferred.
• Strong hands-on programing skills and working experience in CDISC standard, including CDASH/SDTM/ ADaM implementation guidelines, controlled terminologies.
• Critical thinking to solve problems related to non-routine
• Must have a high degree of accuracy and attention to
• Strong organizational skills and ability to work within cross- functional teams.
• Ability to manage multiple initiatives and shifting priorities within a small company
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team

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. 

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliating employees.