Elevar Therapeutics · 1 day ago
Associate Director, Statistical Programming (Remote)
United States
Full-time
Remote
Lead/Staff, Director/Executive
$160K/yr - $195K/yr
8+ years expElevar Therapeutics is a rapidly growing biotech company, and they are seeking an Associate Director, Statistical Programming to lead statistical programming on multiple complex projects. The role involves managing programming teams, supporting clinical study reports, and ensuring deliverables meet regulatory standards.
BiotechnologyHealth CareMedicalPharmaceuticalProduct DesignTherapeutics
Responsibilities
Provide functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval, and market acceptance of Elevar products
This position is primarily responsible for the design, development, and implementation of technical solutions for integrating, analyzing, and reporting clinical data
Drive the development and implementation of innovative strategies and technologies for clinical trial programming
Develop collaborative relationships and works effectively within Biometrics, with external vendors, and members of cross-functional development teams
Provide comprehensive programming leadership and support to complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications, and programmed analysis to comply with regulatory requirements, SOPs, and work practices
This position is responsible for validating programming results generated by external vendors, as well as ad hoc analysis production in-house
Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with pre-defined specifications and standards
Lead the electronic submission preparation and review; develop unambiguous and robust programming specifications
Act as an extended member of the Statistical Programming Leadership Team in sharing and building up the line function vision
Qualification
Required
Bachelor's degree with 12 years; Master's degree with 8 years; or PhD with 5 year's experience in Biostatistics, Statistics
Proven management experience demonstrating business acumen, developing and delivering functional/department goals, delivering results, championing innovation, coaching and developing subordinates including remote and cross-functional teams
Master's Degree in Statistics, Biostatistics, Mathematics
At least 8 years Programming experience in industry including support of significant regulatory filings
Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data
SAS programming experience in oncology studies
Strong collaborative skills and ability to work with a cross-functional team
In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g., MS office, XML, Pinnacle 21)
Demonstrated ability in processing of upstream data (e.g., multiple data forms, workflows, EDC, SDTM, ADaM); demonstrated ability in providing deliverables to meet downstream requirements
Demonstrated ability to work in a team environment with clinical team members
Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
Benefits
Medical
Dental
Vision
Time off
A retirement plan
Other voluntary benefits for employees
Company
Elevar Therapeutics
Elevar Therapeutics specializes in clinical development of promising therapies for unmet medical needs in cancer.
11-50 employees
H1B Sponsorship
Elevar Therapeutics 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
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Early StageTotal Funding
$20M2018-07-25Series Unknown· $20M
Leadership Team
Kenneth Rankin
Vice President of Market Access
Recent News
Elevar Therapeutics
2025-12-03
Company data provided by crunchbase