What are the responsibilities and job description for the Associate Director/Director, Statistical Programming, Biometrics position at Beam Therapeutics?
Company Overview
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
Beam is looking for an associate Director/Director of Statistical Programming to join our growing Statistical Programming team in the Biometrics department. The Associate Director/Director will be responsible for developing and maintaining statistical programming functions within a therapeutic area to support various clinical studies and submissions to ensure successful execution for Beam’s clinical programs. In this role, you will work with the head of statistical programming to develop statistical programming strategies, SAS programming infrastructure as well as department standards, applications and processes. You will manage CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.
Responsibilities:
- Lead and manage statistical programming activities on clinical studies and oversee CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions
- Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs
- Work collaboratively and communicate effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions
- Manage creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources
- Manage the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R
- Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures
- Partner with Statisticians and other members of the clinical study team, perform ad hoc analysis
- Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs and provide expert feedback from functional perspective
- Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities
- Assist the Head of Statistical Programming to develop and implement programming processes, programming standards and SOPs
- Develop SAS programming infrastructure and programming processes to improve data deliverables and ad hoc analyses quality and efficiency
- Build and mentor a team of programmers as needed to support Beam clinical trials and drug development pipelines
Qualifications:
- MS or higher degree in Statistics, Mathematics, or related scientific Discipline
- At least 12 years Pharmaceutical/Biotech programming experience; Level will be commensurate with experience.
- Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
- Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies
- NDA or BLA submission experience is required
- Excellent organizational skills and ability to prioritize tasks
- Excellent communication and interpersonal skills
- Experience managing CROs and other data vendors
- Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance
- Experience with R-Shiny or Python is a plus
