Statistical Data Sciences Lead

Key Skills

AWS, Azure, Continuous Integration & Continuous Delivery - CI/CD, Data science techniques, JavaScript, NumPy, Python Programming, SaaS

Job Description

JOB SUMMARY

• A productive, hands-on programmer who applies technical knowledge and practical experience to deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role.

• Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible

• Ensures adherence to high quality programming standards in their daily work.

JOB RESPONSIBILITIES

• Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may be programming

• Ensures appropriate documentation and QC across the lifespan of the study for all of their Programming deliverables

• Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.

• Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.

• Will be knowledgeable in core safety standards as well as TA standards pertinent to their project, may aid in development of standards necessary for their study may contribute to department level initiatives.

QUALIFICATIONS / SKILLS

• Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.

• At least 8-15 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.

• Statistical Programming and SAS hand-on experience

• Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.

• Good understanding of ICH and regulatory guidelines

• Working knowledge of clinical data and relevant data standards

• Strong written and oral communication skills, and project management skills

• Proven ability to operate with limited oversight

• Knowledge of at least 1 Therapeutic Area

• Proven ability to manage delivery under tight timelines.

• CDISC experience desirable