What are the responsibilities and job description for the Senior SDTM Programmer position at Cytel - USA?
CP Sr. SDTM Programmer (FSP)
Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members.
As aSenior SDTM Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM) tosupport or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development,or Medical Affairs.
Qualifications and Experience:
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members.
As aSenior SDTM Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM) tosupport or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development,or Medical Affairs.
- In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. Knowledge of SAS is required, may include SAS, R, Python, etc..
- Expert knowledge of Define.xml, SDTM aCRF, cSDRGs.
- Expert knowledge of data structures (e.g., CDISC SDTM, CDISC CT) and their implementation.
- Experience in working with SDTM Conformance Checks
- SDTM mapping is a must
- Technical Data Management experience and experience working on a clinical trial.
- 3-5 years experience
- Preparing and validating submission packages, i.e. define.xml, Reviewers Guide
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
Qualifications and Experience:
- BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Must have relevant industry experience
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Strong SAS data manipulation, analysis and reporting skills.
- Ability to implement the latest CDISC SDTM standards (production/validation).
- Experience and or familiarwith Pinnacle21
- Submissionsexperience utilizing define.xml and other submission documents such as SDRG
- Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease strongly desirable.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
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