Senior Statistical Programmer (Remote - Brazil) Biometrics BRAZIL

MMS Holdings Inc; São Paulo; Híbrido; BRL 180 000 - 240 000; Tempo integral

Resumo da oferta

MMS Holdings Inc. in a data-driven CRO environment is hiring a full-time Statistical Programmer to work remotely from Brazil.

You will generate tables, listings, and graphs from clinical trial databases using SAS, and apply SDLC principles to all programming deliverables. The ideal candidate has a Master’s degree in Statistics, 5+ years of experience, expert knowledge of SAS, SDTM and ADaM, ISO 9001/27001 familiarity, and strong communication to collaborate with study teams and regulatory

Qualificações

• Masters required for Statistics roles.
• 5+ years’ experience in Statistical Programming or similar field.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Excellent problem-solving and communication skills.

Conhecimentos

SAS programming

SDLC

SAS Base & Macros

E-Submission Standards

SDTM standards

ADaM standards

MS Office

ICH 21 CFR Part 11 & ISO 9001

Data pooling for submissions

BIMO outputs & define.xml

Lead study teams

Formação académica

Master's degree in Statistics or related field

Descrição da oferta de emprego

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is aaward-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate.We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visitwww.mmsholdings.comor follow MMS onLinkedIn.

We are looking for a full-time employee, remotelybased within any location in Brazil.

Job Specific Skills:

• Mastery and trained ongenerating tables, listings, and graphs from clinical trial databases using SAS.
• Utilizes System Development Life Cycle (SDLC) for programming deliverables.
• Advanced user in SAS programming, SAS Base, and SAS Macros.
• Advanced knowledge of E-Submission Standards, Guidelines and Regulations.
• Mastery and trained on SDTM standards including ability to write specifications.
• Advanced knowledge of ADaM standards including supporting specification writing.
• Proficient with MS Office applications.
• Advanced knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements.
• Advanced experience with pooling of data sets for submissions.
• Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
• Lead study or small programming project teams.

Job Requirements:

• Masters required for all Statistics roles.
• Minimum of 5 years’ experience in Statistical Programming or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.