Statistical Programmer

Senior Statistical Programmer (Contract), BiometricsJOB DESCRIPTION: We are seeking a highly motivated individual to join us as a Senior Statistical Programmer (Contract). You will work with the Biometrics team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to a Senior Manager, Statistical Programming.The Senior Statistical Programmer (Contract) will participate in all programming aspects within a clinical study or indication, including generation of standard and derived datasets, programming documentation, and tables, figures, and listings (TFLs) for all analyses. The Senior Statistical Programmer (Contract) will also support programming activities and publications for translational research, data documentation and archival, and interaction with regulatory authorities regarding filing structure and data content. Additionally, the Senior Statistical Programmer (Contract) will provide technical consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality. Responsibilities (include but are not limited to): Ability to apply knowledge of SAS programming application and other software languages and tools along with knowledge of industry-accepted standards, including CDISC SDTM and ADaM Provides programming expertise and input to planned and unplanned analyses, including the structure of standard and derived datasets, and the planned documentation of programming activities and TFLs.Provides strategic guidance and in-depth critical review for the development of Case Report Forms (CRFs) and database designs; ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Maintains programming documentation and ensures archival and reproducibility of all analyses. Follow and implement standards related to derived data sets and submission data sets Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.Requirements: BS or MS in biostatistics, statistics, computer science, or mathematics 5+ years experience in statistical programming in a pharmaceutical company or contract research organization Advanced and broad knowledge of SAS, along with understanding of industry practices related statistical analyses, programming, and programming documentation Ability to learn new programming languages as required Hands-on experience in CDISC standards and datasets (SDTM, ADaM) Experience in oncology clinical trials and data derivations Excellent verbal, written, and presentation skillsSr. Statistical Programmer- Clinical 12 month contract 100% Remote/Home Based Strong focus will be on SDTM experienceBA/BSc or higher degree in Computer Science, Statistics, Mathematics, Life Sciences or other related scientific subject, or work experience equivalent Greater than 5 years of relevant career experience programming in a clinical development environment Excellent SAS data manipulation, analysis and reporting skills Ability to provide quality output and deliverables Ability to write, test, and validate SAS programs, and review resulting output and data. Excellent oral and written English communication skills Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data Good knowledge of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) an