Sage Therapeutics Senior Statistical Programmer, Consultant in Cambridge, Massachusetts
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for ensuring the robust application of clinical data and statistical programming methodologies to support the development and execution of clinical development strategies to deliver medically-differentiated therapies that provide meaningful improvement to patients. Statistical Programming personnel work closely with the biostatistics, data management, medical writing, and clinical operations development functions to ensure that Sage’s development programs and their component clinical studies have timely and high-quality deliverables. The core responsibilities of Senior Statistical Programmer Consultant include implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses and out-sourced clinical trials, commercial requests and biostatistical ad-hoc analyses.
Roles and Responsibilities
The Sr. Statistical Programmer Consultant is responsible for all statistical programming deliverables in support of the design, conduct, analysis and reporting phase of one or more clinical trials. He/she works independently to support various programming activities related to the analysis and reporting of clinical study data. The Sr. Statistical Programmer Consultant may also serve as statistical programming lead on one or more programs, working closely with other statistical programmers, study biostatistician and biostatistics program lead, study data manager, study medical writer, and other functional area study leads as required. General areas of responsibility also include programming, specification development, analysis datasets (e.g., SDTM/CDISC, ADaM) creation, as well as mapping specifications to support relevant data standards. The main focus of this role will be on analysis/ADAM programming/validation. The successful candidate will:
Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
Develop SAS programs that support regulatory requests, ISS/ISE analyses, commercial requests, biostatistical ad-hoc analysis
May have to create SAS utility macros; write and implement test plans to support SAS macro development
Review and validate CRO deliverables
Lead and oversee programming activities performed CRO programming and biostatistics team.
Review ADAM specs, datasets, define and reviewer’s guide for multiple studies
Performs quality review on SAS programs generated by other statistical programmers
Helps solve critical issues requiring SAS expertise
Understands and follows FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions
Keeps informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings
Assist in other programming tasks using software other than SAS (e.g. SQL) to support specialized data analysis requirements
Ensure that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines
Enjoy working collaboratively as part of a team
Be capable of handling multiple priorities
Adapt to changing priorities, take initiative and follow through on own
Be attentive to details and ability to independently resolve a variety of issues without close supervision
Be independent creative thinker
Have excellent interpersonal skills
Be able to manage multiple projects/tasks, and appropriately prioritize these tasks
Be able to oversee programming work performed by Contract Research Organizations
Experience, Education and Specialized Knowledge and Skills
7 years of experience in pharmaceutical industry
At least 8 years Excellent SAS programming skills and extensive experience working with BASE SAS, SAS GRAPH, and SAS macro programming.
Proficiency in statistical procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED),
In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.
Submission experience (including review of Defines/aDRGs)
Understanding of SAS database structures and experience with at least one Clinical Database Management System (e.g. Medidata RAVE, Oracle inform, etc.)
Excellent communication skills (verbal, written and interpersonal)
Regulatory submission programming is a plus
Ability to work well within multi-disciplinary teams and has proven abilities to coordinate and drive projects in a matrix organization
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
Excitement about the vision and mission of Sage
Number of Openings:
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All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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