Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & 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 & therapeutic areas; 8 successful phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
As the centralized engine for innovation & development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio.
Position Title: Director, Statistical Programming
Position Location: New York, NY (location arrangements are flexible, however)
Manager Title: Head of Biometrics
The Director, Statistical Programming will be responsible for day to day statistical programming tasks for all studies conducted by Roivant Sciences and/or subsidiaries including oversight of CRO statistical programming activities & collaborate with other functional areas such as data management & biostatistics. The Director of Statistical Programming will provide technical support for ongoing trials, FDA submissions, publication & other business needs. The Director of Statistical Programming provides an expert-level hands-on support & technical leadership to all clinical development programs & regulatory submissions. The Director, Statistical Programming will report to the VP of biometrics & Data Management & will work closely with cross-functional teams on multiple clinical development programs. This position is a remote, work from home opportunity.
- Leads statistical programming oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, & approval of programming deliverables.
- Develops & maintains data management SOPs & policies as required to maintain overall quality & consistency of Statistical Programming.
- Participate & provide strategic guidance in study setup & initiation procedures such as CRF design & review. Demonstrate extensive understanding of SAS programming concepts & techniques appropriate to the pharmaceutical industry.
- Efficiently manage CROs to meet timelines & quality deliveries. Oversee TLFs production & validation, ensuring that CROs, vendors & internal staff meet the highest quality standards per SOPs. Establish optimal relationships with internal customers & colleagues & with new or existing strategic partners & vendors.
- Contribute to the strategic decision-making process involving programming issues for ongoing early & late phase clinical trials
- Communicate how programming decisions impact other functional areas at Roivant.
- Write or review or approve the data specifications for SDTM & ADaM. Create or validate SDTM, ADaM, & TLFs. Track & maintain records for all assigned projects & archiving of trial/project analysis & associated documentation.
- Proficient in applying SAS programming knowledge to solve problems related to non-routine situations & experienced in interpreting statistical analysis plans & developing analysis data set specifications.
- Work collaboratively with multiple stakeholders to manage priorities & resources across therapeutic areas; understand & perform in accordance with regulatory standards & drug development principles.
- Responsible for the creation & accuracy of Regulatory submission data & clinical summary report package; plan, develop, test, & document SAS programs & macros for programming efficiency.
- Develop & utilize study metrics to monitor quality, project status, activities & budget & work with VP of Biometrics & Data Management to identify trends & provide updates for improvements on study level operational performance & quality metrics.
- Performs supervisory duties as needed including but not limited to interviewing, hiring, training, intervention, discipline, & discharging of staff.
- Coaches & mentors staff including initiating & implementing appropriate staff development programs. Meets with staff on a routine basis to review goals & individual development plans.
- Ensures that staff levels are adequate in quality & quantity to meet the forecasted workload. Recommends changes if necessary & justifies them in accordance with company policy.
- Ensures that appropriate training programs are in place so that staff is adequately & properly trained for their job requirements.
- Ensures that all training files are up to date & complete in accordance with SOPs & ICH/GCP.
Skills, Qualifications, & Requirements:
- Bachelors Degree in Statistics, Mathematics, or Computer Science. Masters 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, & SDTM/ADaM standards, medical terminology, medical coding dictionaries, & quality control processes.
Strong hands-on SAS programing skills & working experience in CDISC including SDTM, ADaM, metadata, controlled terminologies, & 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 & FDA requirements with prior experience filing a NDA/MAA/BLA preferred.
Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH & SAS Macro languages.
Strong leadership, interpersonal, organizational, & multi-tasking skills, & ability to work within cross-functional teams.
Ability to manage multiple initiatives & shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently & collaboratively in a dynamic team environment.
Ability to apply technical knowledge to work activities & use critical thinking skills for problem identification & solving; ability to prioritize & effectively manage multiple projects simultaneously.
Ability to work with little or no supervision with accuracy & thoroughness. Excellent written & oral communication skills.