SAS - Clinical Senior Biostatistics Lead

Domain: HealthTech
Career Path: AgileData
Type: Full Time preferred

Seniority: Mid senior level
Location: Cambridge or MetroWest, MA or Greater New York and New Jersey

Skills

  • A minimum of 5 years of experience programming with SAS in the pharmaceutical or related industries
  • Proficiency in SQL and PL/SQL programming
  • Proficient in SAS programming, including BASE, FSP and SAS macro programming
  • Understanding of SAS database structures and experience with at least one Clinical Database Management System (e.g. Oracle Clinical, Clintrial, eDM, etc.)
  • Understanding of ICH GCP as well as knowledge of industry practices and standards
  • Written and oral communication and presentation skills
  • Familiarity with CDISC/SDTM/ADaM data standard specifications
  • Adaptive and Bayesian design experience is a plus
  • Fluency in English, both oral and written

Education

PhD. in Biostatistics or related field with at least 3 years of directly related experience in the pharmaceutical/biotech industry, or M.S. with at least 6 years of directly related experience.

Experience

Experience working on all phases of clinical trials (Phase 3 international clinical trials is a plus)
Experience working on NDA/BLA/MAA development and submissions, including hands-on experience working on ISS/ISE

Description

We are seeking a creative, resourceful, integrative thinker for an important role that is responsible for ensuring the robust application of traditional and emerging statistical methodologies to support the development and execution of clinical development strategies. Biostatistics personnel work closely with the regulatory affairs, medical science, clinical operations development, medical affairs, and translational science functions to ensure development programs and their component clinical studies have high quality statistical analysis plans that satisfy desired messaging and study objectives, and that the analyses are completed on time and with high quality. Biostatistics personnel work closely with the biostatistics, data management. Medical writing, and clinical operations development functions to ensure that development programs and their component clinical studies have timely and high quality deliverables. Biostatistics personnel participate in the development and execution of clinical study protocols, case report forms, and data management plans, and support data monitoring and cleaning to enable effective and efficient clinical trial execution.

SAS Developers with Clinical experience

Essential Duties & Responsibilities

The Senior Biostatistics Lead 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 Senior Biostatistics Lead will also serve as statistical programming coordinator on one or more programs, working closely with the statistical programming program lead, 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 import/export programming, specification development, analysis datasets (e.g., SDTM/CDISC, ADaM) creation, as well as mapping specifications to support relevant data standards. The successful candidate will:

  • Participate in a number of new drug development programs, and provide strategic and technical support in the design, execution of clinical development plans, clinical trials, and statistical analysis plans
  • Serve as biostatistics program lead for assigned compound(s) and/or study biostatistician
  • Manage and oversee junior biostatisticians working on studies within his/her assigned compound(s) to insure timely and high-quality biostatistics deliverables
  • Develop computer programs using SAS and performs the necessary manipulations to import external data into SAS or export SAS output to other computer files
  • Develop computer programs, using primarily SAS, to create and derived data sets and perform other advanced data manipulation
  • Assist with the development of advanced computer programs, using SAS and other software if necessary, to perform system tasks and macros/utilities to increase the quality and efficiency with which results are produced
  • Ensure that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines
  • Assist in other programming tasks using software other than SAS (e.g. SQL) to support specialized data analysis requirements
  • Prepare documents to describe SAS programs and databases for large projects
  • Perform Quality Control (QC) procedures
  • Assist with the development of computer programs, using primarily SAS, which generate complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs
  • Assist with database development responsibilities
  • 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 and independent creative thinker
  • Have excellent customer relation skills
  • Be able to manage multiple projects/tasks, and appropriately prioritize these tasks
  • Be able to oversee programming work performed by Contract Research Organizations

SAS - Clinical Senior Biostatistics Lead

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Arrayo is an Equal Employment Opportunity employer and as such does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.