Senior Manager, Statistical Programming

Autolus Therapeutics

18h

About The Position

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours. Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, pension and access to an employee share scheme. Autolus promotes flexible working. Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees A Sr. Statistical Programming Manager provides timely support to the project team on all programming matters according to the project strategies. As an integral part of a project team, the incumbent provides project leadership and contributes to the programming support for processing data from clinical studies. Project requirements will be identified according to a Statistical Analysis Plan, programming specifications or user requirements/design documents using internal standards and guidelines. The incumbent is responsible for leading the programming aspect of the project, both internally or CROs, for all programming deliverables and participates in the identification and development of programming standards and macro development to facilitate the creation of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. May be asked to oversee special projects / work with clinical task force. Meets statistical ad-hoc requests of senior management.

Requirements

Bachelor’s degree in life science, statistics, mathematics, computer science, or related field is required; Master’s degree is preferred.
7 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions.
Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
Demonstrated expertise in the handling and processing of upstream data.
Demonstrated expertise in providing outputs to meet downstream requirements, e.g., SDTM, ADaM, Data Specification, e-submission.
In-depth understanding of regulatory, industry, and technology standards and requirements.
Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
Demonstrated ability to work in a team environment with clinical team members.
Excellent planning and project management skills.
Good interpersonal, communication, writing and organizational skills.
Keep abreast of evolving regulatory, industry, and technology changes and demands, e.g., CDISC, SDTM, ADaM, eDC.
Good written and verbal communication skills.
Knowledge of appropriate FDA and EMA regulations, industry standards and guidance documents.
Understands clinical research process, trial designs, and the development of protocols and analysis plans.
Shows expert knowledge of the SAS programming language, including SAS Base/Macro/STAT/Graph/ODS.
Proficient in computer skills relevant to programming and analysis environments.

Responsibilities

Independently coordinate and oversee the preparation, execution, reporting and documentation of clinical project programming activities.
Provide programming input to CRF, SAP, data specifications, and tables, figures, and listings (TFLs) shells.
Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
Perform ad-hoc flexible and rapid programming arising from questions generated from planned analyses and results.
Ensure consistency and adherence to standards.
Work with external vendor (e.g., CROs) on programming deliveries.
Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
Provide programming support for the preparation of integrated reports, health authority submissions and post-submission activities.
Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
Routinely interface with cross-functional team members.