Senior Statistical Programmer - SDTM

Company: Cytel Inc
Location: Rockville
Posted on: June 9, 2021

Job Description:

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

As a Senior SDTM Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support 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
• Technical Data Management experience and experience working on a clinical trial.
• 3-5 years experience

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
• Applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
• Generating complex ad-hoc reports
• Preparing and validating submission packages, i.e. define.xml, Reviewers Guide
• Applying your strong understanding/experience with Efficacy analysis;
• Preparing submission packages
• Performing lead duties when called upon;
• 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 / ADaM standards (production/validation). ADaM efficacy dataset development is required.
• Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
• Proficiency in SAS  MACRO development
• Strong ad-hoc reporting   
• Solid experience in Efficacy analysis
• Experience and or familiar with Pinnacle21
• Submissions experience utilizing define.xml and other submission documents such as SDRG, ADRG
• 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.

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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.

Keywords: Cytel Inc, Rockville , Senior Statistical Programmer - SDTM, Other , Rockville, Maryland