Statistical Programming Lead

Pay 70-80/h depending on experience

Purpose and Scope:

Member of cross-functional teams, the primary purpose of the position is to act independently and contribute to clinical studies or Medical Affairs studies, Exploratory/Regional work supporting complex/novel work within a development program (clinical/ observational studies, MA tactic, PK/PD and Biomarker analyses or regional project). This includes global accountability of all programmed deliverables at the study and submission level within assigned programs in one or more Primary Focus (PF) areas. In addition, the position is responsible for programming vendor oversight for assigned compounds and contributes to functional/departmental infrastructure projects.

The position acts independently as Global Programmer Lead (GPROGL) for an early stage or non-complex asset, supports the data transparency effort by programming statistical summaries for regulatory-mandated disclosure and represent the company on programming matters during inspections.
Under guidance, the position can also support the generation of complex TLFs, act as GPROGL late phase or offer training/mentoring to other programmers.

Responsibilities and Accountabilities:

For clinical trials, post marketing or early phase support and for asset support:
• Is responsible for the high-quality, on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)),
• Is a key collaborator with statistics in ensuring that specifications are complete and statistical plans are executed efficiently with the right level of validation.
• Is the single point of contact for assigned studies, coordinates the activities of the programming team internally, and liaises with the lead programmer at the vendor (as applicable).
• Enforces the company's, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards) so that deliverables are ready to be used in regulatory submissions.

Personal development / Collaboration
• Actively participates in the development and implementation of programming tools for Statistical Programming infrastructure projects.
• Leads Statistical programming activities related to the disclosure of company clinical trial data to regulatory agencies and research-based sites.
• Is responsible to efficiently communicate, at regular intervals, to Global Programmer Lead (GPROGL) and/or line management on study/project/initiative status and resource issues.

Required Qualifications:

• Bachelors or masters in statistics, mathematics, or related field
• 6+ years (9+ years for Bachelor) of experience of relevant programming experience in the pharmaceutical industry and working with vendors
• 2+ years experience as a lead programmer for a drug development program