INACTIVE
Full-Time
Associate Director
Clinical-stage company advancing cell therapies for solid tumors
Biotechnology
$190000 - $205000
Senior
Washington, USA
Required Skills
SQL
Data Analysis
Google Cloud Platform
Requirements
- This position requires extensive programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers
- Bachelor's or master's degree in Statistics or Mathematics, Computer Sciences, IT, or related fields
- Minimum of 6 years experience in the Pharmaceutical Industry, or relevant Regulatory environment
- Thorough knowledge of CDISC SDTM, ADaM, Define.xml, and other industry standards, and ability to implement the standards
- Strong knowledge of the clinical development process, GCP/ICH standards, and global regulatory submission requirements
- Working knowledge of current regulations, familiarity with eCTD format and content of regulatory filings with prior experience filing a BLA/MAA/NDA
- Current knowledge of technical and regulatory requirements relevant to the statistical programming role
- Ability to apply programming expertise to problem-solving and troubleshooting for teams
- Proven ability to operate with limited oversight
- Ability to effectively manage multiple tasks and projects. Demonstrate planning and project management skills
- Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures
- Experience in working with an outsourced model
Responsibilities
- The Statistical Programming Associate Director is accountable for the quality, timely and efficient delivery of project programming work with good quality
- Oversees and manages external vendors to ensure high-quality deliverables and manage timelines for the outsourced deliverables
- Develops and validates standard department/generic macros and template programs
- Effectively manages, develops, and reviews the analysis datasets, TLF's, and other deliverables as required
- Provides expert-level hands-on support for the statistical programming deliverables including but not limited to the regulatory, publication, Adhoc requests, post-hoc, and exploratory data analyses
- Leads and directs the full scope of project delivery and/or leads a technical project within the drug product/study/function
- Leads Implementation of statistical programming aspects of the protocol or clinical development program
- Leads or contributes to cross-functional administrative or process improvement initiative(s)
- Participates in the development, maintenance, and adherence to departmental SOPs and Guidelines
- Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function
- Drives or supports standards development and implementation in statistical programming function
- Manages and escalates risk in complicated situations within their study and/or projects
- Provides input and/or drives improvement of processes and programming implementation
- Maintains expertise in the latest industry and regulatory requirements to stay current
- Manages and is willing to coach and mentor junior or contract programmers
- Lead the projects for the programming deliverables and milestones from study start-up to regulatory submission
- Work with the study, product, and biometrics team in goal and timeline setting
- Develop or review technical programming specifications and programs, and generation of SDTM and ADaM datasets, Tables, Listings, and Graphs
- Support, validate, and maintain programming infrastructure and standard department macros and template programs to ensure high-quality and efficient deliverables
- Review documents for submission readiness and conformity to company and health authority guidelines eg SDSP, ADRG, cSDRG
Company Stage
N/A
Total Funding
$1.1B
Headquarters
South San Francisco, California
Founded
2018
Growth & Insights
Headcount
6 month growth
↓ -17%1 year growth
↓ -12%2 year growth
↑ 0%INACTIVE