Job Directory Audentes Therapeutics Associate Director, Senior Statistical SAS Programmer
Audentes Therapeutics

Associate Director, Senior Statistical SAS Programmer Audentes Therapeutics
San Francisco, CA

Audentes is a biotechnology company that employs gene therapy technology to develop treatments for people with rare muscle diseases.

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About Audentes Therapeutics

Job Description

Associate Director, Senior Statistical SAS Programmer

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.

Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.

The Role

Reporting to the Senior Director, Biometrics, the Associate Director/Senior Manager, Senior Statistical SAS Programmer will provide programming expertise on multiple clinical trials from database development per CDISC standards to developing Tables, Listings and Figures using global and study specific macros. AAV Gene Therapy is an innovative, and potentially transformative way of treating severe, genetic diseases. The position will be located in our San Francisco offices. Working in this ultra-rare indication environment and in this capacity, some of the biggest interpersonal and technical challenges are the following:

The specific responsibilities of this position include:

* Participate in Database UAT testing
* Attend internal meetings, including study team meetings, and external meetings as needed
* Vendor management and interactions on external data transfers and DTP standards
* Develop SDTM and ADaM specifications and datasets
* Develop define.xml and RGs for submissions
* Develop and manage junior and contract programmers developing Tables, Listing and Figures per the SAP, DMC, or annual Safety report specifications
* Maintain a validated SAS server at all times
* Ensure SOP training are current and as needed
* Validate and QC SAS programs as needed
* Provide ad-hoc and exploratory analysis support
* Understands importance of timelines and documentation, and strives to meet them at all times
* Proven ability to prioritize tasks, delegate or escalate as needed
* Able to operate in a validated 21CFR Part-11 compliant environment

Required Education, Skills and Experience

* BS degree in computer science, statistics, mathematics or related areas and 8+ years' direct and related experience in pharmaceutical and biotechnology industry. A very clear and proven hands-on experience with safety annual reports, integrated analyses Excellent understanding of relational database and ability to participate in CRF development and database UAT testing, and attention to details
* Proven ability to write cross-referencing check programs
* Strong hands-on familiarity with SAS programming language BASIC, GRAPH, STATS
* Strong hands-on familiarity with statistical analyses procedures including Repeated Measures, Survival, and other relevant analyses
* Successful experience with SAS graphical presentations and ODS output
* Successful history and experience with CDISC standards and development
* Excellent understanding of clinical trials and regulated and GCP compliant working environment
* Excellent oral and written communication skills
* Demonstrated positive attitude, able to follow instructions and always reliable
* Proven ability to work independently as well as collaboratively and to adapt to change
* Desire to be creative and proactive
* A strong collaborator with a proven ability to build professional relationships, with internal and external partners
* Commitment to Audentes' values: Be BOLD, Care deeply, and #GSD (Get Stuff Done)
* Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks, timelines, and priorities efficiently and effectively

Preferred Education, Skills and Experience

* Statistical degree
* Familiarity with rare indication
* Experience in managing others
* Familiarity with IND/BLA electronic submission requirements

About Audentes Therapeutics

Audentes is a biotechnology company that employs gene therapy technology to develop treatments for people with rare muscle diseases.

Size
97 employees
Audentes Therapeutics

600 California St, San Francisco

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