Manager / Senior Manager Statistical Programming

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:  launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 successful phase 3 readouts since 2019.  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 first large 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 Manager/Sr. 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 Manager of Statistical Programming provides an expert-level hands-on programming support to all clinical studies and regulatory submissions. The Manager/Sr. 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, immunology or anti-infectious disease studies. 

Responsibilities

• 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.

Skills, Qualifications, and Requirements

• Minimum 7 -12 years Bachelor’s / Master’s Degree in Statistics, Mathematics, or Computer Science.
• Track record 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. 

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