Description
Senior Manager of Statistical ProgrammingA rapidly expanding pharmaceutical company located in the San Francisco Bay Area seeking a highly qualified Senior Manager to lead the Statistical Programming department. This is an exciting opportunity to joining a thriving team in working on new innovative projects within this year. Seeking to hire immediately if all qualifications are met.
Requirements:
- A minimum of 5 - 8 years of SAS programming experience in the pharmaceutical or biotechnology industry with a BA/BS, or MA/MS with 4 years of experience.
- BS/BA in Statistics, Computer Sciences, Mathematics, Life Sciences; MA/MS preferred.
- Experience in the management of people and projects
- Experience in working in and contributing to cross-functional teams
- Proven track record in forming and managing a functional team to support multiple projects.
- Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment.
- Experience with Clinical Study Reports and NDA submissions.
- Oncology experience preferred.
- Experience in data management a plus.
Responsibilities include the following:
GENERAL
- Develop and implement improved programming processes and methods
- Ensure consistency in infrastructure within the Statistical Computing organization.
- Manage department quality requirements in coordination with Regulatory Compliance and IT.
- Collaborate with functional management across the organization on project deliverables and timelines for projects within area of responsibility.
- Manage group of internal programmers, consultant programmers, and CROs.
- Collaborate with other Biometrics functions for all activities related to analyses of clinical trial data.
- Responsible for execution of ad hoc requests, manuscripts, and presentations.
- Oversee all programming support activities for a clinical program in line with acceptable statistical methodology, timely and accurate data integration, analysis and interpretation of results.
- Oversee the preparation and review of programming deliverables for clinical study reports and scientific presentations; participate in team review of documents.
- Determine documentation and archival standards of statistical programming deliverables including analysis databases, summaries, programs, and specifications.
- Support achievement of major reporting deliverables and milestones for regulatory submissions.
- Performs (or assigns/supervises) project management for programming deliverables in a project..
- Establish and negotiate timelines with internal and external team members for completion of activities for a group of projects.
- Train and manage employees and consultants within area of responsibility.
- Responsible for budget and resource planning for statistical area.
STANDARDS
- Adhere to principles of GCP
- Develop, apply and promote consistent programming standards through standard processes and SOPs.
- Identify areas of deficiency requiring SOPs or guidelines and execute a plan to rectify..
- Follow guidelines and specifications on validation procedures and data transfer procedures.
- Maintain appropriate documentation surrounding maintaining or archiving clinical data and/or programs.
COMMUNICATION
- Facilitate communication with and provide guidance to CROs/external vendors (e.g., data management CROs, bioanalytical labs, and analysis consultants) to achieve defined objectives by stipulated timelines
- Maintain open communication within department to manage priorities
- Provide guidance to consultants and new hires regarding department standards and GCP
To find out more about Real please visit www.realstaffing.com