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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

Employment Type:

Contingent Worker

Number of Openings:

1

Job ID:

R000661

#Biotechnology #Careers #ThisIsSage

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.

EEO is the Law (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law - Poster Supplement

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

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