For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Essential Functions
:
Participates in and contributes to the training and development of more junior biostatisticians
Independently reads and comprehends study design and statistical sections of a protocol and appropriately adapts protocol language to a statistical analysis plan.
Able to work with clients to procure operational design information for sample size calculations.
Independently able to perform and QC sample size calculations.
Able to independently review data management documents to assess quality of the documents to support statistical analyses.
Independently develop Randomization specifications and programs based on study requirements.
Prepares draft statistical analysis plans and shells.
Able to perform review of draft SAP and shells produced by more junior biostatisticians.
Reviews PD file for exclusion from analysis sets and implements into specifications and/or programs.
Participates in unblinding activities and incorporates unblinded treatment codes into algorithms/programming
Able to read and understand most SDTM & ADaM domains and mapping algorithms. Able to review common domains independently. Understands the role that SDTM & ADaM plays in the standardization of clinical trials data/CDISC.
Able to prepare specifications for moderately complex analysis data sets (CDISC and CDISC-like) independently or highly complex data sets with senior oversight.
Able to develop programs to produce and perform statistical review of datasets, listings, tables and graphs as outlined by a statistical analysis plan.
Able to effectively QC TLFs, SDTM and analysis data sets (ADaM/non-ADaM) independently.
Able to effectively review the statistical section of CSR for statistical accuracy with minimal input from senior oversight.
Able to maintain biostatistical section of TMF independently
Able to attend project team meetings and contribute to project team discussion of project related issues
Able to effectively interact with both internal and external clients on project issues.
Respects and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
Able to keep detailed records of time spent on each project to allow accurate billing and maintains awareness of overall biostatistics budget and time spent on projects that they are assigned to lead.
Develops and maintains overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
Deepens their knowledge of clinical research including awareness and understanding of how biostatistics interacts with other team members on a project.
Perform other work-related duties as assigned
Necessary Skills
and A
bilities
:
In-depth knowledge of statistical methodologies and how to apply them in a clinical research setting.
Demonstrated working knowledge of advanced clinical trial design and analysis principles.
Competent knowledge of CDISC standards and application of these standards to projects.
Strong computer skills, with evidence of advanced programming skills (SAS or R) especially statistical inferential procedures
Excellent English Communication skills (verbal, written & interpersonal).
Detail oriented, well organized.
Ability to multitask and work effectively in a fast-paced environment with changing priorities.
Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment.
Excellent Communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners.
Excellent team player, collaborative and able to work as part of an effective team. Maintains a positive, results orientated work environment
Educational Requirements:
Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
Experience Requirements:
5 to 8 years' experience in clinical trials design and analysis
Outsourcing industry experience
required
.
Experience in clinical trial design, sample size calculations, and statistical analysis.
Experience with CDISC data structures, such as SDTM and
ADaM
.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***