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This apprenticeship standard is in development and is not yet ready to use

Why is this apprenticeship not ready for delivery?

An apprenticeship standard is only available for delivery when both the standard and assessment plan is approved and a funding band (core government contribution) has been assigned to the standard.

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If you'd like to get involved and contribute to the development of this standard, please read about developing standards and assessment plans. You can email the trailblazer contact using the details on this page.

Overview of the role

Provide statistical leadership to a multi-disciplinary team.

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Medical statistician

Details of standard

Occupation summary

This occupation is found in a wide range of industries including the Pharmaceutical, Health Care, Medical Device Technology, Biotechnology, Food and Environmental Safety, Regulatory and Academic sectors.  The name Medical Statistician and biostatistician are synonymous.  For simplicity and alignment to terminology used in numerous universities Medical Statistician is used for this apprenticeship. The broad purpose of the occupation is to provide statistical leadership to a multi-disciplinary team, to ensure research studies are designed, conducted, analysed, interpreted and reported in a way which is statistically valid, such that conclusions are trustworthy and reliable.  Research studies are conducted in a wide variety of settings, often designed to test potential new treatments for diseases or to investigate new healthcare interventions.  Studies collect data, which is then analysed in order to provide evidence based decisions on whether the new treatment/intervention is advantageous to the patient’s condition (e.g. extending life, reducing symptoms or slowing disease onset), whilst ensuring that any unwanted side effects of the treatment are acceptable for the improvement gained.  Once enough evidence is gathered, the new treatment/intervention is submitted to a regulatory body for review, with the hope it is approved to be given to patients outside of the research study setting. In their daily work, an employee in this occupation interacts with with regulatory bodies, ethics committee’s senior management, study directors, scientists and doctors, data managers, clinical teams, project managers and medical writers to ensure the work they conduct is statistically valid. The role requires good problem solving skills, applying statistical theory to ensure appropriate conduct, and meaningful, reproducible and appropriately interpreted results. The role of a Medical Statistician is primarily office-based spending their time designing studies, monitoring studies, analysing data, writing reports and contributing to team discussions in meetings. The role may also involve some travel to company sites, conferences, scientific and regulatory meetings, workshops and seminars. In an academic setting a Medical Statistician will also have some interaction with students. An employee in this occupation will be responsible for writing/reviewing statistical sections of protocols (including trial design, randomisation schema, study endpoints and sample size), review and input into study collection materials (electronic Case Report Forms, vendor devices), statistical analysis plans (SAPs) (including specifying the format and structure of planned analysis outputs), contributing to grant applications and creating reports for groups such as data monitoring committees. The occupation also involves programming in a statistical package, such as SAS®, R or other appropriate software, creating summaries and graphical representations and performing analyses of data.  They ensure statistical model assumptions based on statistical theory have been met and the analyses applied are appropriate. They provide statistical leadership and oversight of a study to a study team as well as managing their own day-to-day workload to ensure project deliverables are met. They interpret the analyses performed, and contribute to study reports and publications such as manuscripts, posters and slide presentations, to ensure results are appropriately disseminated.  A Medical Statistician will also be responsible for keeping abreast of current methodological developments in medical research through reading of journals and attendance at conferences, including publishing their own methodology research and sharing knowledge through statistical tutorials for statistics colleagues and also non-statistical specialists.

 

Typical job titles include:

Biostatistician Medical statistician Statistician

Entry requirements

Typical entry requirements are a 2.2 degree in a numerically based subject.


Occupation duties

Duty

KSBs

Duty 1 Lead on the statistical design of medical trials and research projects.

K3 K4 K6 K7 K10 K11

S1 S6 S8 S9 S10 S16

B1 B2 B4 B5

Duty 2 Calculate appropriate sample size in medical research to answer the medical research question of interest.

K1 K3 K11

S3

B3 B5

Duty 3 Produce technical writing in medical research

K1 K5 K10

S1 S2 S5 S6 S8

B3 B4

Duty 4 Plan, oversee and perform data collection and selection of endpoints/variables in medical research for the therapeutic/disease area of interest.

K1 K4 K10 K12

S1 S2

B1 B2

Duty 5 Select and apply statistical methods applicable for medical research and interpret results

K1 K4 K10

S1 S2 S3 S5

B3

Duty 6 Carry out data visualisation for reporting of medical research:

K1

S2 S4

B3

Duty 7 Critically review medical scientific literature and contribute to ongoing medical research publications

K1

S2 S7 S12 S13 S17

B4

Duty 8 Lead, support and advise on statistical aspects of trials or studies.

K1 K2 K3 K6 K7 K10 K11

S1 S2 S5 S6 S7 S8 S9 S10 S11 S16

B1 B2 B3 B4 B5 B6

Duty 9 Effectively communicate the results from both basic and advanced statistical methods used in medical research

K2 K5

S2 S5 S6 S7 S8 S16 S17

B1 B2 B3 B4 B5

Duty 10 Develop self and others through demonstration of best practice by effective coaching, mentoring, teaching and training.

K6 K8 K9

S6 S7 S8 S14 S15 S16 S17

B1 B2 B4 B6


KSBs

Knowledge

K1: Statistical knowledge of methods that are commonly used in medical research and enable effective analysis of data in research studies. Back to Duty

K2: Project management techniques and strategies (meeting timelines, managing budgets and contingency planning). Back to Duty

K3: Statistical knowledge that enables effective research study design (for example: the drug development process; Study design - parallel group, cross-over, adaptive, placebo controlled, active comparator, open label; Methods allied to different trial objectives – superiority, non-inferiority and equivalence; Randomisation and blinding; Methods for data presentation; Estimands; Missing data strategies; Multiple testing and alpha control methods; Simulation; Sample size and power calculations; Complex innovative designs (CID)). Back to Duty

K4: Strategic approaches to risk and compliance in relation to study design and data collection and interpretation. Back to Duty

K5: Communication and influencing techniques and strategies, both written and oral (including presenting). Back to Duty

K6: Leadership and management techniques and strategies, including coaching and mentoring techniques. Back to Duty

K7: The structure and function of a multidisciplinary team and the role of the Medical Statistician within it, and how to achieve effective partnership working. Back to Duty

K8: Learning and development strategies, to enable personal and professional development, including giving and receiving feedback and critical reflection. Back to Duty

K9: The importance of continuing personal and professional development and the role of critical reflection in maintaining fitness to practice. Back to Duty

K10: Awareness of key regulatory authorities and documentation relevant to the study they are working on (International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use Guidelines; European Medicines Evaluation Agency (EMEA); Pharmaceutical and Medical Devices Agency (PMDA); Food and Drug Administration (FDA); The National Institute for Health and Care Excellence (NICE); Medicines and Healthcare products Regulatory Agency (MHRA); Therapeutic area specific guidance; Good Clinical Practice (GCP); Good Laboratory Practice (GLP);Good Manufacturing Practice (GMP). Back to Duty

K11: Ethics in clinical and non-clinical research. Back to Duty

K12: Methods to safely store and handle data in line with national and international data protection and cyber security regulations. Back to Duty

Skills

S1: Interpret, apply and comply with legislation, statutory frameworks, professional codes of practice and guidance, including quality control. Back to Duty

S2: Select and perform the appropriate statistical technique that are commonly used in medical research relevant to the given data set and objective. Back to Duty

S3: Use statistical software (SAS® and R or other appropriate software) to perform the required statistical methods that are commonly used in medical research. Back to Duty

S4: Use statistical software (SAS® and R or other appropriate software) to create appropriate graphical and tabular representations of the data to aid interpretation that are commonly used in medical research (such as summary tables, individual data listings, histograms, boxplots, scatter plots, line charts, bar charts, frequency tables). Back to Duty

S5: Assess and interpret the results of data analysis and communicate these to peers in written and verbal discussion (such as written medical statistical reports and oral presentations). Back to Duty

S6: Adapt communication technique when communicating statistical concepts to different audiences including people from a non-scientific background. Back to Duty

S7: Critique technical documents affecting projects they are working on, written by other professionals (e.g. medical writers, study directors, project managers, medical consultants). Back to Duty

S8: Provide statistical input into the preparation of technical documents, e.g. study protocols, statistical analysis plans (including specifying the format and structure of planned regulatory required analysis outputs), study reports, regulatory submissions and grant applications. Back to Duty

S9: Identify issues that can affect projects, finding solutions that meet the commercial demands of the business environment. Back to Duty

S10: Lead projects to completion within agreed and defined timescales and project parameters. Back to Duty

S11: Work within limits of personal and professional competence, justifying and taking responsibility for own actions and seeking advice when required. Back to Duty

S12: Search and critically appraise scientific literature, including literature on new and emerging methods and techniques relevant to medical statistics. Back to Duty

S13: Evaluate new statistical methodologies relevant to medical statistics. Back to Duty

S14: Facilitate learning and provide feedback to others as appropriate. Back to Duty

S15: Critically review own practice and identify areas for personal and professional development. Back to Duty

S16: Collaborate with other professionals to deliver mutually agreed outcomes. Back to Duty

S17: Contribute to the wider statistical community (including their own organisation), through sharing knowledge, such as peer review, authorship and co-authorship of papers for publication or presentation at conference. Back to Duty

Behaviours

B1: Be open, honest, compassionate, act with integrity at all times, observe duty of candour and maintain confidentiality. Back to Duty

B2: Be respectful, non-judgemental and engage with people in an inclusive and non-discriminatory manner. Back to Duty

B3: Maintain good ethical character as outlined in professional GCP/GLP/GMP regulations (Code of Conduct with a “Subject first attitude”) and refrain from activities which would bring the profession or organisation into disrepute. Back to Duty

B4: Be adaptable and able to respond professionally to all feedback. Back to Duty

B5: Be prepared to challenge and/or report inappropriate behaviours and practices, using established procedures. Back to Duty

B6: Take a proactive approach to own personal wellbeing, and that of others, reporting concerns as appropriate. Back to Duty


Qualifications

English & Maths

Apprentices without level 2 English and maths will need to achieve this level prior to taking the End-Point Assessment. For those with an education, health and care plan or a legacy statement, the apprenticeship’s English and maths minimum requirement is Entry Level 3. A British Sign Language (BSL) qualification is an alternative to the English qualification for those whose primary language is BSL.

Other mandatory qualifications

Medical Statistics

Level: 7 (integrated degree)


Additional details

Occupational Level:

7

Duration (months):

30

Review

This apprenticeship standard will be reviewed after three years

Status: In development
Proposal approved Standard approved Assessment plan approved
Level: 7
Degree: integrated degree
Reference: ST0892
Route: Health and science
Typical duration to gateway: 30 months (this does not include EPA period)
Trailblazer contact (for apprenticeship standard content and trailblazer membership queries only): jim.saul@covance.com
Employers involved in creating the standard: Covance, GSK, Phastar, Roche, Amgen, Worldwide Clinical Trials, Quanticate, Parexel, Pfizer, Sosei Heptares, Reckitt Benckiser, Qiagen, Astrazeneca, Fera Science
EQA Provider: Office for Students

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