This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.
- The Staff Analyst, Statistical Programming is a newly created opening to serve in a lead function overseeing the development, testing, validation, documentation, maintenance, and execution of SAS programs. This individual will primarily be providing statistical programming support for THV Medical Affairs department.
- Provide programming expertise on one or more clinical trials in programming, documentation, validation and review of summary tables, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statistician.
- Lead in programming analysis datasets.
- Provide programming expertise on ad hoc data requests in collaboration with project statistician.
- Develop program specifications and design documents in partnership with project statistician.
- Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review.
- Mentor, coach, and provide guidance to junior-level programmers.
- Collaborate with CDM to review draft CRFs (Case Report Form), databases and perform edit checks.
- Partner with clinical data management team to ensure that the databases is defined consistency across clinical trials.
- Participate in the development of procedures (e.g. SOP development and standardization of output).
- Assist in compiling technical documents for internal and external audits; Other duties assigned by Leadership.
#MIEducation & Experience:
- Master’s degree in Statistics, Mathematics, Computer Sciences (or related field) and 6 years of clinical trial experience within the medical device or pharmaceutical industries. Cardiovascular device experience preferred OR
- Bachelor’s degree in Statistics, Mathematics, Computer Sciences (or related field) and 8 years of clinical trial experience within the medical device or pharmaceutical industries. Cardiovascular device experience preferred.
- Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus).
- R programming experience is highly preferred
- Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel.
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.
- Keeps abreast of new developments in statistics and regulatory guidance.
- Extensive understanding and knowledge relevant to statistical programming.
- Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to a Pharmaceutical/Medical Device research setting.
- Excellent problem-solving, organizational, analytical and critical thinking skills.
- Strong leadership skills and ability to influence change.
- Ability to provide training and coaching to lower level employees.
- Experience in facilitating change, including collaboration with management and executive stakeholders.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including serving as consultant to management.
- Ability to interact with suppliers, vendors and/or customers.