Open Positions: Associate Director, Statistical Programming
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
The Associate Director, Statistical Programming will be responsible for day to day statistical programming tasks for all studies conducted by Arvinas including oversight of CRO statistical programming activities and collaborate with other functional areas such as clinical research, data management, biostatistics. The Associate Director of Statistical Programming will provide technical support for ongoing clinical trials, FDA submissions, publication and other business needs. The Associate Director, Statistical Programming will work closely with cross-functional teams on multiple clinical development programs.
This position reports to the Head of Biostatistics and Data Management and can be remote, hybrid or located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Act as statistical programming subject matter expert (SME) to support outsourced programming activities to ensure CROs meet timeline and quality of programming deliverables and be responsible for the programming technical decision and planning. Assist in review of key study documents (e.g., statistical analysis plan (SAP), data management plan, case report form (CRF), EDC data structures, data review plans, etc.).
- Review CRF annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.
- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission Q&As, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or regulatory meeting preparation.
- Develop and maintain necessary statistical programming macros or tools to effectively support all programming needs.
- Work collaboratively with Collaborate with multiple functions to maximize automation processes for data extraction, reconciliation, data review listings and patient profiles to expedite clinical data review and cleaning.
- Build statistical programming talent team to provide adequate programming support for clinical development at Arvinas and to ensure that staff levels are adequate in quality and quantity to meet the forecasted workload.
- Set up statistical programming SOPs, work processes and collaborate with IT team to set up statistical programming infrastructure for operational excellence.
- Minimum 10 years of statistical programming experience in CRO, biotech, or pharmaceutical industry with at least 3 years' programming leadership experience. Oncology experience preferred.
- 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.
- 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.
- Ability to apply technical knowledge to work activities and use critical thinking skills for problem identification and solving; ability to prioritize and effectively manage multiple projects simultaneously.
- Ability to work with little or no supervision with accuracy and thoroughness. Excellent written and oral communication skills.
- Bachelor's Degree in Statistics, Biostatistics, Mathematics, Computer Science or related fields.
- Master's Degree preferred.
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity employer