Associate Director/Manager, Statistician
PRESTIGE BIOPHARMA LIMITED
Healthcare / Pharmaceutical
S$4500 - S$8000
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed and accepted for review with the EMA in 2019 and will also be filed with the US FDA in 2020. Prestige BioPharma’s next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in Phase I stages.
With its strong development pipeline, Prestige Biopharmaceuticals continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in developing drugs that can help people around the world.
- You will work in project teams alongside colleagues from all specialties to ensure that statistics projects are completed to an exceptionally high standard, on time and in line with the team’s expectations.
- The data management team is growing quickly, and so the successful applicant will be someone who shows the potential to increase their value quickly.
- We are particularly keen to hear from talented and motivated individuals who can efficiently manage the different needs of the project, and possibly progress into a leadership role in the data management team.
- While the team will initially focus on a single early stage project, this will rapidly grow to a role supporting the planning of several clinical trials as well as regulatory filings at one time.
- The analysis generated will need to be explained and presented to the project teams and/or regulators, thus an individual with good communication skills is highly desired.
- Overall, you will be exposed to a number of exciting projects each with their own challenges in various areas of biotherapeutics.
- Performs statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
- Prepare statistical analysis plan
- Present and explain statistical findings
- Responsible for the quality and timeliness of all statistical deliverables of the assigned studies
- Create study design and analysis planning based on study outline
- Reviews protocols to ensure statistical integrity and optimal study designs
- Contribute to setting up various data management tools such as eCRF and Design Surveys and Questionnaires
- Reviews and provides input into critical documents
- Contributes to clinical study reports and provides statistical interpretation of the results
- Ensures quality and consistency of key data science deliverables across assigned studies within a project
- Conduct or supervise exploratory data analysis of datasets and baseline variables.
- Involve in the coordination of data summaries and analysis activities
- Supports creation of indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.
- Contribute to data cleaning
- Any other duties assigned by the Presidential Office.
- A degree level or higher qualification in a scientific or mathematical discipline (minimum 2.1, CAP 4 or GPA 4) is required, although a Masters or PhD would be highly advantageous.
- Proven experience working as a lead statistician in Pharma, Biotech or CRO environment.
- Proven knowledge of statistical methods for design of clinical studies and analysis of clinical date
- Proficiency in the R and SAS programming language, and the willingness and ability to rapidly develop your programming skills
- A minimum of five years’ work experience in medical statistics
- Good understanding of GCP is required
- Implementation and adherence to Guidelines for Standard Operating Procedures (GSOPs) for good statistical practices (ICH E9) is a must
- A willingness to trial, explore or recommend new software or techniques that may suit specific projects
- A desire to apply your statistical knowledge and technical skills to the healthcare industry
- A high degree of accuracy and attention to detail, along with the ability to maintain a high level of customer service and the quality of deliverables under multiple competing demands
- Highly organised, with the flexibility to respond to changing deadlines
- The ability to use your initiative and work independently, in addition to working collaboratively within project teams
- Excellent written English is fundamental; this will be assessed during the selection process
- Singaporeans and Permanent Residents are preferred
Closing on 31 Mar 2021