Sr. Statistical Programmer

Therapeutics Inc.•San Diego, CA

2d•$100,000 - $140,000•Remote

About The Position

Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently. Your Main Responsibilities and Duties Include: Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications. Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files. Perform quality control for SAS programs and other study documents (e.g., presentations and reports). Maintain complete and auditable documentation of all programming activities. Review output across SAS programs to ensure consistency. Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. Assist Clinical Data Managers with data review via SAS programmed data checks and listings. Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures. Participate in the development and/or maintenance of departmental procedures and standards. Review CRFs, edit check specifications, and table mock-ups. Work collaboratively with cross functional groups, study team, and vendors. May assist in creation of table, figure, or listing mockups under supervision of statisticians. You should have a Bachelor’s degree in Statistics, Mathematics, or in a related field; Master’s preferred. You should have a minimum of 8 to 10 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer is required. You should have a knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL. You should be able to demonstrate extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines. You should possess excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines. You should also possess excellent communication and interpersonal skills to effectively interface with others. If you have NDA submission experience that is a plus, but not required. The most likely base pay range for this position is $100,000 - $140,000 per year. Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual’s exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.

Requirements

You should have a Bachelor’s degree in Statistics, Mathematics, or in a related field; Master’s preferred.
You should have a minimum of 8 to 10 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer is required.
You should have a knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
You should be able to demonstrate extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
You should possess excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
You should also possess excellent communication and interpersonal skills to effectively interface with others.

Nice To Haves

If you have NDA submission experience that is a plus, but not required.

Responsibilities

Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
Maintain complete and auditable documentation of all programming activities.
Review output across SAS programs to ensure consistency.
Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
Assist Clinical Data Managers with data review via SAS programmed data checks and listings.
Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
Participate in the development and/or maintenance of departmental procedures and standards.
Review CRFs, edit check specifications, and table mock-ups.
Work collaboratively with cross functional groups, study team, and vendors.
May assist in creation of table, figure, or listing mockups under supervision of statisticians.