TheRas Inc

Compensation

Full Description

Description: About BBOT BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com Who You Are This is an exciting opportunity for a highly motivated Senior Manager or Associate Director with a strong background in Statistical Programming. We are looking for a talented and enthusiastic individual who thrives in a collaborative, fast-paced, and growing environment to join our team to lead statistical programming activities for one or more compounds, indications, or therapeutic areas. In addition to direct programming and technical oversight of one or more studies, this position may require assistance providing technical support and guidance during regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. As a key member of the Biometrics team, you will: Responsibilities • Lead programming efforts for one or more clinical studies, acting as the primary point of contact for programming deliverables. Review and approve all programming outputs to ensure accuracy and consistency. • Provide technical oversight of statistical programming resources including contractors and CROs. Ensure quality and timely delivery of analysis for statistical programming deliverables. • Lead or participate in vendor selection processes and provide input on proposals, budgets, and timelines as needed. Collaborate with Clinical colleagues and FP&A to prepare and/or review financial documents, such as accruals, invoices, change orders, budgets, etc as needed. • Collaborate with colleagues from all functional areas, including Statisticians, Data Management, Clinical Development, Clinical Operations, Safety, Regulatory, Medical Writing, and others as needed to ensure timely and high-quality deliverables. • Represent the Statistical Programming function in cross-functional team meetings. Participate in review of key study documents (e.g., SAPs, CRFs, DMPs, database specs, DMC charters). Partner with Program Manager(s) to develop and maintain timelines for statistical deliverables. • Create SAS programs to develop informal data deliverables, and/or validate SDTM datasets, ADaM datasets, and TFL outputs according to CDISC and internal standards. Ensure full regulatory compliance and maintain traceability. • Ensure accurate ADaM programming specifications and indices of programming deliverables are maintained. Create or review and approve SDTM mapping specifications, annotated CRFs, and key SDTM domains. Create or review and approve documentation for regulatory filings, including reviewers' guides and data definition documents. • Drive the development of departmental standards, SOPs, macros, tools, and processes that improve the efficiency of producing analytics across programs. Adopt a strategic approach to producing analytical deliverables, incorporating innovative tools and methods where needed. • Participate in audit/inspection activities related to statistical deliverables as needed. • Directly manage or indirectly mentor and provide technical guidance to junior-level statistical programmers as needed. Requirements: Education and Qualifications • BS or MS preferably in Data Science related fields (e.g. Statistics, Mathematics, Epidemiology, Health Economics, Computer Science, Bioinformatics, etc.). • Minimum of 6-8 years (Senior Manager) or 10-14 years (Associate Director) of Statistical Programming experience in the analysis of clinical trial data. Direct statistical programming experience for early or late-phase oncology clinical trials to support production/verification of analysis datasets, tables, listings, and figures. • Minimum of 2 (Senior Manager) – 4 (Associate Director) years of demonstrated leadership experience managing projects, vendors, and people. • Must have advanced knowledge in Base SAS, SAS Macro, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS. • Expertise with CDISC standards and regulatory agency data guidelines. • Submission experience highly preferred. • Proficiency in R, Python, Spotfire, Tableau, and/or other programming languages and visualization techniques a plus. • Strong problem-solving skills and a commitment to continuous learning and development. Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important. • Ability to excel in a highly-collaborative and innovative environment. Compensation BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role. Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.