- Collaborate with internal and external functions to plan and execute programming deliverables.
- Develop and execute statistical analysis and reporting deliverables in a timely and high-quality manner.
- Review or author SDTM and ADaM datasets specifications for datasets programming.
- Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for ADaM datasets, fit-for-purpose analysis, and TLFs.
- Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
- Provide programming support for adhoc analysis and for preparation of publications, including manuscripts and posters etc.
- Review key study-related documents including but not limited to SAP, annotated case report form, data management plan, database specifications, EDC data structures specs.
- Participates in the development of overall objectives and influences long-term goals of the team.
- Other duties as assigned.
- Bachelor’s degree in Life Science, Statistics, Mathematics, or Computer Sciences is required. Master’s degree preferred.
Experience and Skill Requirements:
- Minimum of 12 years of SAS programming experience within a Pharma / Biotech or CRO.
- Solid SAS programming skills and experience with CDISC, SDTM, ADaM and Pinnacle 21. Good programming skill in MACRO is needed.
- Experience in the analysis of complex oncology clinical trial data. Knowledge of immuno-oncology is a plus.
- Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH).
- Strong knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.).
- Prior experience filing a BLA or NDA preferred.
- Ability to manage multiple initiatives and shift priorities within a small company environment.
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
Replimune is an equal opportunity employer.
EEO & Employment Eligibility
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.
Replimune now requires Covid vaccination disclosure for all US employees.