Senior Biostatistician

TOTAL TRIALS INC; Centurion; On-site; ZAR 1,000,000 - 1,500,000; Full time

Job summary

FHI Clinical in South Africa seeks a Senior Biostatistician to lead statistical activities on clinical projects in compliance with ICH GCP and global guidelines. You will write SAPs, create analysis datasets, and oversee TFL development and reporting.

The role requires expert SAS programming, data validation, and collaboration with study teams, vendors, and clients, including manuscript support and DSMB liaison.

Qualifications

• Master's degree in statistics, biostatistics, bioinformatics, mathematics, public health or related field.
• 5-8 years of relevant work experience in statistical analysis of research studies.
• Strong leadership, mentoring, and collaboration skills.
• Excellent written and verbal communication in English.

Responsibilities

• Write statistical analysis plans (SAPs) and statistical programs to generate tables, listings and figures.
• Perform statistical analyses and validate analysis data sets and TFLs.
• Develop and maintain analysis data sets and TFL specifications.
• Draft statistical sections of study reports and contribute to manuscripts.
• Provide statistical input to study teams on randomization and analysis conduct.
• Support DSMB meetings and communicate timelines and data quality issues.
• Guide and oversee direct report(s) including workload and career development.
• Ensure compliance with ICH GCP, FDA/EMA guidelines and procedural documents.
• Refine protocols and manuscripts; maintain program documentation.

Job description

The Senior Biostatistician will be responsible for biostatistical aspects, as applicable, of clinical projects undertaken by FHI Clinical, in accordance with the relevant protocol and other trial-related documentation, ICH GCP (and applicable local adaptations thereof), other local legal requirements, relevant FDA, EMA, and other international guidelines, as well as FHI Clinical (and sponsor, if applicable) Procedural Documents.

The Senior Biostatistician will write statistical analysis plans (SAPs), perform statistical analyses, oversee the work of team members performing tasks associated with providing statistical services, and contribute to and review study reports.

The Senior Biostatistician will interact proactively with other study team members, vendors, and clients on study set-up (including randomization) and conduct statistical project management (including timelines and financial oversight). The Biostatistician will communicate with team members regarding trial conduct related to timelines, data quality, and interpretation of results.

The Biostatistician will contribute to developing and maintaining the data written by investigators in other departments' departmental systems, including management tools. The Biostatistician may also referee protocols and manuscripts written by investigators in other departments or divisions.

The Biostatistician will provide and oversee statistical support, as applicable, for clinical projects undertaken by FHI Clinical. The Biostatistician will interact proactively with clients regarding statistical issues as they arise. The Biostatistician will communicate with team members regarding trial conduct related to timelines, data quality, and interpretation of results.

Essential Functions:

• Using specification documents, write statistical analysis programs using SAS or other statistical software to generate or validate analysis data sets and tables, figures, and listings (TFLs) for statistical reports.
• As validator, investigates sources of discrepancies in data and/or program code. Reviews completed TFLs for accuracy, including textual material (titles, headings, footnotes, etc.).
• Write and maintain accurate program documentation and generate TFL shells from existing macros or other sources.
• Develop analysis data sets and TFL specifications.
• Write analysis programs in SAS or other software.
• Design and generate TFL shells and analysis data set specifications, using protocol, statistical analysis plan, or other study materials.
• Carry out intermediate to advanced statistical analysis and assess the validity of analysis assumptions.
• Help draft statistical sections of study reports.
• Review study reports and manuscripts for accuracy of reporting and inference.
• Write SAS or other software analysis programs for complex and/or critical analyses.
• Provide statistical input and expertise to the study team on all aspects of study conduct that impact analysis or other statistical tasks (e.g., randomization).
• Provide medical writing assistance as and when required.
• Provide support to DSMB meetings, blinded or unblinded.
• Assist the Global Head with delegated tasks and responsibilities, including but not limited to support in preparing and reviewing Procedural Documents, resource allocation, utilization and forecasting, budget review, bid defenses, etc.
• Provides guidance and oversight to direct report(s), including managing workload, special projects, performance management, salary review, and career development.
• Any other duties and responsibilities that may be assigned occasionally.

Knowledge, Skills, and Abilities:

• Excellent judgment and decision-making skills.
• Uncompromising attention to detail and the ability to think analytically.
• Able to communicate in English effectively and accurately, orally and in writing.
• Ability to communicate and interact effectively with non-statistical colleagues on project teams.
• Ability to prioritize workload.
• Effective organizational and negotiating skills.
• Excellent interpersonal skills and problem-solving ability.
• Medical writing skills.
• Highly developed computer skills, including expertise in biostatistical software packages and the ability to learn appropriate software as necessary.
• Proficient knowledge of therapeutic areas.
• Proficient knowledge of all FHI Clinical Procedural Documents, ICH GCP and local legal requirements, European, FDA and other relevant international guidelines applicable to clinical research.
• Be able to maintain a high level of confidentiality.

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Position Requirements

Education:Master' degree or international equivalent in statistics, biostatistics, bioinformatics, mathematics, public health, or a related field is required.

Preferred Job-related Experience:A minimum of 5 - 8 years relevant work experience in statistical analysis of research studies.

Additional Eligibility Qualifications:Demonstrated proficiency in functions required for a lead statistician, including interpersonal and communication skills necessary for effective interactions with study teams. Demonstrated skills in multiple statistical areas and/or therapeutic indications. Experience in statistical aspects of study design. Experience providing statistical consultation to researchers.

Preferences:Minimum of two (2) years experience as supervision or manager of staff.

Special Position Requirements:Proficiency in SAS.

Physical Expectations:

• Typical office environment.
• Ability to sit and stand for extended periods of time.
• Ability to spend long hours looking at computer screens and doing repetitive work on a keybord.
• Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements

Expected travel time is less than 10 % for this position.