BBOT · 6 hours ago
Senior Manager/Associate Director, Statistical Programming
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$187K/yr - $215K/yr
6+ years expBBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. They are seeking a highly motivated Senior Manager or Associate Director with a strong background in Statistical Programming to lead statistical programming activities for clinical studies and ensure compliance with regulatory standards.
Biotechnology
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
Qualification
Required
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
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
Preferred
Submission experience highly preferred
Proficiency in R, Python, Spotfire, Tableau, and/or other programming languages and visualization techniques a plus
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
H1B Sponsorship
BBOT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase