Associate Director Statistical Programming
- R+D/ Global Development Support
- Greater Boston area
- $150,000 - 190,000 +complete benefits package
An exiting pharmaceutical company is looking to hire an Associate Director Statistical Programming. This position reports to the Senior Director, Statistical Programming. This candidate will be accountable for the statistical programming implementation of clinical trials, cooperate with statisticians and data managers to ensure high quality and timely statistical programming deliverables, ensure compliance to internal standards and SOPs. This position will serve as the in-house statistical programming expert and deliver consultation to other functions.
The AD Stat Programming position will have responsibilities that include:
- Synchronize and implement on the preparation, execution, reporting and documentation of statistical programming activities, proactively identifying issues and recommending solutions
- Delivers state-of-the-art programming knowledge/skills for process development initiatives or other major change initiatives
- Efficiently monitors quality within area of responsibility, including both internal and outsourced activities
- Actively contributes in the development and implementation of Statistical Programming objectives
- Implements industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards)
- Work closely with clinical operations, data management and statisticians to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch
- Liaise with vendors as needed to facilitate electronic data transfers and statistical programming
The ideal candidate will have the following skill set:
- Requires a Bachelor's degree or higher in Statistics or Biostatistics. MS degree or PhD preferred with 5+ years of statistical programming experience in pharma/biotech
- Experience working in an outsourced statistical programming model
- Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH)
- Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.)
- Prior experience filing a BLA or NDA preferred
- Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation.
- Ability to problem solve.
- Excellent verbal and written communication skills in a global environment.
- Ability to identify and define departmental goals and objectives.
- Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook)
- Demonstrated leadership in a cross-functional team setting
- Ability to manage multiple initiatives and shifting priorities within a small company environment
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment