Sr Statistical Programmer

Syneos Health, Inc.; Johannesburg; Remote; ZAR 600 000 - 900 000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Statistical Programmer to develop custom programming code and ensure quality outputs in clinical trials. The role involves collaboration with teams and mentoring junior staff, making a significant impact on patient therapies.

Qualifications

• 5-8 years experience as Senior SP, or 3-5 years as SP II.
• End-to-end experience in ADAM, TFLs, and SDTM.

Responsibilities

• Develop custom programming code for generating summary tables and derived datasets.
• Ensure outputs meet quality standards and project requirements.
• Act as lead statistical programmer, directing activities and monitoring progress.

Skills

SAS

R

Communication

Education

Undergraduate degree in a scientific or statistical discipline

Tools

ADAM

TFLs

SDTM

Job description

Updated : October 22, Location : South Africa-Europe - ZAF-Home-Based Job ID : Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient.

We continuously seek to simplify and streamline our work to make Syneos Health easier to work with and for. Whether in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate therapy delivery because we are passionate about changing lives. Why Syneos Health?

We are committed to developing our people through career growth, supportive management, technical and therapeutic training, peer recognition, and a total rewards program. Our Total Self culture allows you to be your authentic self.

This culture unites us globally, and we prioritize taking care of our people. We are building the company we want to work for and that our customers want to collaborate with.

Why?

Because diversity in thoughts, backgrounds, cultures, and perspectives enables us to create an inclusive environment where everyone feels they belong.

Job Responsibilities

1. Use SAS or other software to develop custom programming code for generating summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications.
2. Ensure outputs meet quality standards and project requirements.
3. Perform validation programming and collaborate with Programmers, Biostatisticians, and project team members to resolve discrepancies.
4. Keep team members informed of progress and issues.
5. Follow SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
6. Maintain organized documentation, testing, verification, and quality control documents, ensuring inspection readiness.
7. Manage scheduling and prioritize across multiple projects, set goals, and adapt to changes.
8. Develop specifications for datasets and outputs according to requirements.
9. Anticipate programming issues, establish efficient processes, and define variables clearly.
10. Prepare for meetings, contribute ideas, and respect others’ opinions.
11. Distribute meeting minutes promptly and accurately.
12. Follow through on action items, maintain order, and work toward consensus.
13. Collaborate with others and assist with projects as needed.
14. Negotiate and establish realistic time estimates for programming activities.
15. Act as lead statistical programmer, directing activities and monitoring progress.
16. Review project documentation such as SAP, mock shells, programming specs, annotated CRFs, and SAS database design.
17. Provide feedback to improve efficiency.
18. Participate in sponsor meetings, kickoff, and bid defense meetings as the programming representative.
19. Mentor programming staff through training, review, and guidance.
20. Transfer deliverables and perform other duties as assigned. Minimal travel may be required.

Qualifications

• Undergraduate degree in a scientific or statistical discipline; equivalent experience may be considered.
• Experience as Senior SP (5-8 years), SP II (3-5 years), or Prin SP (5-8 years).
• End-to-end experience in ADAM, TFLs, and SDTM.
• Experience in R preferred but not mandatory, with a focus on clinical domain.
• Experience in therapeutic areas is acceptable.
• Extensive programming experience in SAS or similar software in a clinical trial environment.
• Excellent communication skills in English.

We encourage diverse applicants, even if their experience doesn't perfectly match. Transferable skills are valued. Join our Talent Network to explore more opportunities.

At Syneos Health, we work hard and smart to deliver therapies to those in need. A career here means making a global impact on patients’ lives.