Senior Statistical Programming

at  Cytel South Africa Proprietary Limited

South Africa, , South Africa -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate12 Oct, 2024Not Specified12 Jul, 2024N/AComputer Science,Regulatory Requirements,Color,Referrals,Communication Skills,StatisticsNoNo
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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 5 years 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:

The Senior Statistical Programmer leads the programming activities for a trial, early phase project, indication, or publication activities. 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. If the programmer is delegated as a lead there may be additional responsibilities for monitoring and meeting assigned program milestones as well as leading a small team of statistical in-house or consultant programmers to accomplish tasks.
Essential functions include creating systems that assist the Statistical 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 Senior Statistical Programmer must follow established standardized design and programming procedures; provide mentoring to junior level Statistical Programmers; assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities; and develop and maintain clinical processing work flow systems.
The Senior Statistical Programmer works on the Client’s systems and under the Client’s SOPs/processes. The Functional Service Provider (FSP) 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