– Initially remote due to pandemic, eventually onsite
This is a joint appointment within Biometrics and Clinical Pharmacology. This position will report directly to the Director of Statistical Programming with coordinated supervision by the Sr. Director of Clinical Pharmacology. This individual will utilize a variety of analytic software to integrate PK drug concentration-time measures, pharmacodynamic responses, and clinical safety and efficacy information for PK/PD and Modeling and Simulation (M&S) analyses. This position will also work closely with other members of the Biometrics team to provide programming support across clinical development programs. The successful candidate will be familiar with quantitative approaches in drug development and have hands-on experience with relevant software (e.g. SAS, NONMEM, Phoenix, R, SimCYP).
- Under the supervision of the ClinPharm lead, deliver the PK/PD elements of the ClinPharm strategy.
- Plan and generate analysis datasets (SDTM, ADaM, M&S, SEND), statistical tables, figures, and listings, along with supporting documentation, with specific focus on ClinPharm deliverables.
- Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with the ClinPharm lead, and Biometrics lead, and other study programmers to meet timelines.
- Ensure quality of project programming deliverables.
- Provide input on programming methodologies to support the clinical development process.
- Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, Biology, Chemistry, Pharmaceutical Sciences, or a related technical discipline; MS preferred.
- Minimum of 4 years’ experience in clinical research, ideally as a programmer or analyst for phase I-III clinical trials in a pharmaceutical/CRO environment.
- Technical knowledge of and experience with SDTM, ADaM, SEND, and Define.XML. Experience with PopPK or ClinPharm M&S is a plus.
- Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
- Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Experience with R or familiarity/experience with NONMEM, Phoenix, R, or SimCYP is a plus.
- Ability to effectively communicate and perform in a high demand and dynamic working environment.
- organizational skills; and capable of working on multiple projects simultaneously under tight timelines or heavy stress.
- Ability to develop and maintain timelines.
- Demonstrates ability to interact professionally with personnel at all levels within and external to the company and be dependable and a team player.
- Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
- Accountability – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions.
- Self-motivated and can independently manage responsibilities.
- Strong communication skills and interpersonal skills.
- Demonstrates ability to interact professionally with personnel at all levels within and external to the
- Ability to travel (<10%).