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 Director/Senior, Statistical Programming will be responsible for strategic oversight and day to day statistical programming tasks for all 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 incumbent will be accountable for developing a best-in-class statistical programming function.
The Director/Senior Director, Statistical Programming will report to the VP of biometrics and Data Management and will work closely with cross-functional teams on multiple clinical development programs. This position is a remote, work from home opportunity.
- Builds up an in-house programming group capable of supporting future trials and provides oversight of on-going trials.
- Leads statistical programming oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and approval of programming deliverables.
- Efficiently manage CROs to meet timelines and quality deliveries. Oversee TLFs production and validation, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs.
- Develops and maintains programming SOPs and policies as required to maintain overall quality and consistency of Statistical Programming.
- Demonstrates extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Contributes to the strategic decision-making process involving programming issues for ongoing early and late phase clinical trials.
- Writes or reviews or approves the data specifications for SDTM and ADaM. Create or validate SDTM, ADaM, and TLFs. Track and maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
- Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas; understand and perform in accordance with regulatory standards and drug development principles.
- Be responsible for the creation and accuracy of Regulatory submission data and clinical summary report package; plan, develop, test, and document SAS programs and macros for programming efficiency.
- Develops and utilizes study metrics to monitor quality, project status, activities and budget and work with cross functional team to identify trends and provide updates for improvements on study level operational performance and quality metrics.
- Performs supervisory duties as needed including but not limited to interviewing, hiring, training, etc.
- Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans.
- Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload. Recommends changes if necessary and justifies them in accordance with company policy.
- Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements.
- Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP..
Skills, Qualifications, and Requirements:
- Bachelor's Degree in Statistics, Mathematics, or Computer Science. Master's Degree preferred.
- Minimum 10 years of statistical programming experience in CRO, biotech, or pharmaceutical industry with at least 5 years' management experience.
- Strategic leadership in a cross-functional team setting with extensive experience in an outsourced model, EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical terminology, medical coding dictionaries, and quality control processes.
- 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.
- Advanced knowledge in GCP, ICH, GCP/ICH standards, 21 CFR Part 11 and FDA requirements with prior experience filing a NDA/MAA/BLA preferred.
- Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.
- 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.
- Ability to work with little or no supervision with accuracy and thoroughness. Excellent written and oral communication skills.
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.