Statistical Programmer II

at  Cytel South Africa Proprietary Limited

South Africa, , South Africa -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate19 Jan, 2025Not Specified19 Oct, 2024N/AComputer Science,Statistics,Regulatory Requirements,Communication Skills,Color,ReferralsNoNo
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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.

QUALIFICATIONS AND EXPERIENCE:

 Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 3 year of SAS programming experience with clinical trial data.

  • Minimum Work Requirements: General knowledge of regulatory requirements and drug development process.
  • Skills: Excellent organizational skills and good verbal and written communication skills. Ability to work independently is required

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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Responsibilities:

Working under the direction of the Technical Manager/Associate Director /Director, Statistical Programming, the SAS programmer conducts statistical programming activities for the reporting of clinical study data. Develops and supports statistical programming computer systems that are used in the production of statistical analysis plan (SAP)-planned tables, data listings, and graphs, integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles. Essential functions include creating systems that assist the biostatistical programming staff and biostatistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications; developing systems to support electronic regulatory submissions; providing systems and support for clinical data management staff, clinical programmers, quality control (QC) staff, and biostatisticians; producing and supporting systems that extract data from the clinical database; and building analysis databases composed of SAS datasets. The SAS programmer must follow established standardized design and programming procedures; develop, enhance, evaluate, and validate standardized macros and utility programs; and ensure that regulatory requirements are met through validation/compliance activities. The Statistical Programmer works on the Client’s systems and under the Client’s SOPs/processes. The Functional Service Provider programmers support various projects across the portfolio, by augmenting the Client’s current staff.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

BSc

Computer Science, Statistics

Proficient

1

South Africa, South Africa