Responsibilities:
- The Sr. SAS Programmer will be responsible for statistical programming for the clients clinical studies.
- In this role you will develop and validate SAS programs for data presentation analyses and provide programming support to project team members.
- Our Ideal candidate will have a strong work ethic capable of thriving in a high growth fast paced and intellectual environment.
- Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies.
- Design and perform quality checks on analysis datasets tables listings figures (TFL) and written reports to support clinical trial results using SAS.
- Create and review annotated CRF to STDM datasets.
- Produce and maintain technical programming specification documents.
- Lead and actively participate in client and project review meetings.
- Communicate with clients regarding study protocol or statistical analysis issues.
- Validate statistical deliverables and ensure that appropriate statistical methods are utilized.
- Ensure adherence to industry standards and regulatory requirements.
- Facilitate the development and application of adequate statistical methods in clinical research.
Requirements:
- PhD or MS degree in Statistics Biostatistics or related field.
- 5 years of relevant work experience in CRO biotech pharmaceutical or life sciences industry.
- Familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines (FDA/EMA ICH/GCP).
- Experience with NDA/BLA submission activities.
- Experience in statistical programs such as Statistical Analysis System (SAS) CDISC and SDTM.
- Maintain awareness of industry standards regulatory requirements departmental guidelines and Standard Operating Procedures (SOPs).
- Excellent organizational skills time management ability to prioritize workload and meet deadlines.
- Excellent communication and interpersonal skills to effectively interact with others.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract