Senior Statistical Programmer

General Summary:

The Sr. Statistical Programmer will be responsible for statistical programming support for clinical trials and programs including submissions to Health Authorities. The position will also support in-house ad hoc programming requests (e.g. for abstracts or publications).

Job Duties and Responsibilities:

1. Collaborate with biostatisticians, data managers, and clinical study teams to ensure the accurate and timely delivery of data and analysis results on assigned studies and programs.
2. Serve as the primary point of contact for statistical programming, coordinate outsourced programming activities.
3. Oversee outsourced statistical analysis and reporting deliverables (e.g. safety, efficacy analysis datasets, tables, listings and figures) to ensure compliance with industry standards (CDISC, SDTM, ADaM) and applicable regulatory guidelines.
4. Ensure data packages for health authority submissions comply with applicable submission requirements.
5. Maintain statistical datasets that will support clinical development and safety.
6. Provide statistical programming support for ad-hoc requests (e.g. abstracts, posters, publications etc.)

Minimum Qualifications:

1. Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
2. A minimum of 5-7 years of experience in statistical programming in the pharmaceutical or biotechnology industry.
3. Proven experience in supporting NDA submissions to the FDA.

Differentiating Qualifications:

1. Experience with regulatory agency interactions and audits is preferred.

Skills and Knowledge Required:

1. Extensive experience with SAS and in clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
2. Strong understanding dataset submission requirements in support of approval applications.
3. In-depth knowledge of CDISC standards, including SDTM and ADaM.
4. Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts.
5. Familiarity with clinical data management concepts.
6. Experience assuring programming consistency across protocols and projects.