Our Pharmaceutical client in San Francisco, who has achieved the remarkable accomplishment of bringing several new products to the market in recent years, has an immediate need for an Associate Director, Statistical Programming to join their team on a full-time, direct hire basis.
You will need to have management and training experience in SAS, biostatistics, and clinical drug development. Reporting to the Senior Director, Statistical Programming and Applications you wil provide statistical programming leadership and oversight for all phases of clinical trials and drug development, including regulatory submissions. You will also be responsible for production of statistical programming deliverables, either personally, or by directing and coordinating activities of others, or by supervising one or more programmers, managers, and partnering with vendors and third parties.
• Works with clinical scientists, statisticians, clinical operations, and other programmers to plan the production and generation of datasets and tables, listings, and graphs (TLGs).
• Participates in drug development programs as a Subject Matter Expert (SME) in statistical programming.
• Partners with other functions, CDM, BIOS, and BTO, to create biometric deliverables, e.g., CRFs, analyses, and datasets.
• Responsible for providing programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.
• Works with the Head of the Programming Department and department peers to develop and monitor the department strategic direction and its alignment with company strategies.
• Keeps abreast of literature and advancements in SAS and UNIX.
• Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines.
• Identifies areas of process and efficiency improvement.
• Significant amount of programming of datasets and TLGs.
Qualifications and Skills:
- Minimum educational degree is a BS in Mathematics, Statistics, Biostatistics, Computer Science, or related field. (MS degree in Statistics, Biostatistics, or Mathematics is preferred)
Therapeutic Area Expertise
- Must have a proven track record in the statistical analysis and reporting of Oncology Clinical Trial data. Current on the SDTM and ADaM domains in Oncology, proficient in the statistical analysis of failure time data, and an understanding of analysis of solid tumor data.
- A minimum of 12 years clinical trial experience in pharmaceutical and/or Biotech Company.
- Thorough understanding and proficiency of CDISC, including experience in creating and mapping SDTM and ADaM datasets.
- Experience in submissions, including eCTD and US regulatory experience.
- Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV).
- In-depth knowledge of clinical operations, data management, and clinical study report preparation workflow.• Knowledge of RAVE, or other eCRF collection methods, and providing programming input into CRF creation.
- Proficiency in statistics.
- Ability to interpret statistical analysis plans and table shells to create analysis datasets and TLGs; ability to assist in the creation of specifications for datasets and table shells from the reading of the statistical analysis plan or protocol.
- In-depth knowledge of regulatory regulations and guidelines.
- Advanced knowledge of CDISC requirements for SDTM and ADaM.
- Worked on electronic NDA and/or BLA submissions via eCTD.
- Experience with INDs or CTAs.
Software and Computer Systems
- Advanced knowledge of SAS on UNIX, including statistical procedures, macro, and graphing.
- Proficiency in MS Word, Excel, PowerPoint, and Project.
- Must be able to build high level of rapport and trust with others through dependability and initiative.
- Must be highly motivated and able to work well under pressure and shifting priorities independently as a team leader and as a team member.
- Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
- Ability to complete complex tasks in a timely manner with a minimal supervision.
- Must be able to initiate clear and effective communications across disciplines or divisions in the company, including the biometrics leadership team or the clinical study teams.
- Must be able to provide clear direction to other programmers on the team in order to achieve project goals.