Senior Biostatistician (Home Based - South Africa) Biometrics South Africa

Mms Holdings Inc; Cape Town; On-site; USD 60 000 - 100 000; Full time

Job summary

An award-winning clinical research organization is seeking a Senior Biostatistician to provide critical input into statistical sections of clinical study protocols. In this role, you will develop and review statistical analysis plans, ensure data quality, and collaborate with various teams to support clinical trials. This position offers the opportunity to work in a supportive and innovative environment, contributing to the advancement of clinical research. If you are passionate about statistics and want to make a meaningful impact in the pharmaceutical industry, this is the perfect opportunity for you.

Qualifications

• Master's or PhD in Statistics with relevant experience.
• Strong knowledge of SAS and statistical methods.

Responsibilities

• Develop and review statistical analysis plans for clinical studies.
• Ensure data quality throughout the trial and prepare reports.
• Collaborate with teams to provide input for datasets and analyses.

Skills

SAS

Statistical Analysis

Data Validation

Problem-Solving

Statistical Methods

Interpersonal Skills

Education

Master of Science in Statistics

PhD in Statistics

Tools

MS Office

Job description

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 an award-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-leading 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 maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive.

Join us at MMS and be part of a team shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career.

Visit or follow MMS on LinkedIn.

Senior Biostatistician: Roles & Responsibilities

1. Provide input into statistical sections and overall consistency of clinical study protocols.
2. Develop and review statistical analysis plans (SAP).
3. Determine appropriate analyses for clinical endpoints based on input from the protocol and the client.
4. Perform senior-level reviews and be responsible for datasets and outputs of projects.
5. Ensure consistency with SAP and review for correctness and quality.
6. Collaborate with programming team to provide input for analysis / ADaM datasets for final analyses.
7. Develop specifications and review datasets needed for tables, listings, and graphs (TLGs).
8. Prepare TLG shells / specifications and programming notes based on SAP and datasets.
9. Work with data management team to review data collection and ensure data quality throughout the trial.
10. Perform and coordinate the preparation, execution, reporting, and documentation of high-quality statistical analyses according to SAP.
11. Support programmers and medical writers on statistical matters per client requirements.
12. Prepare and review statistical methods and results sections for the clinical study report (CSR).
13. Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
14. Generate sample size calculations appropriate for primary endpoints based on protocol input.
15. Review randomization schedules per protocol and specifications.
16. Coordinate with project management to ensure appropriate timelines.
17. Stay current with industry practices and regulatory guidelines.
18. Communicate independently with clients regarding statistical and programming considerations.
19. Demonstrate strong understanding of ICH guidelines applicable to statistics.
20. Practice good customer service internally and externally.

Requirements

1. Master of Science in statistics or equivalent with 4+ years relevant experience, or PhD with 2+ years.
2. Strong knowledge of and experience with SAS (SAS Stat, Base, macros, ODS, Graph).
3. Hands-on data validation using SAS.
4. Excellent mathematical and problem-solving skills.
5. Advanced knowledge of statistical considerations in drug development, including clinical trial data.
6. Strong knowledge of study designs and analysis methods (e.g., GLMs, survival analysis).
7. Familiarity with clinical data and databases, including EDC systems.
8. Working knowledge of SDTM / ADaM standards.
9. At least three years of experience in the pharmaceutical industry.
10. Ability to coordinate multiple projects simultaneously.
11. Proficiency with MS Office applications.
12. Good interpersonal, communication, and team skills.
13. Self-motivated, dependable, and positive personality.
14. Effective communication and leadership with statistical programmers.