Interested in a simple Skills Scan and Learning Progress Tracker tool for the Medical statistician standard?
Knowledge
K1: Statistical knowledge of methods that are commonly used in medical research and enable effective analysis of data in research studies.
K2: Project management techniques and strategies (meeting timelines, managing budgets and contingency planning).
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)).
K4: Strategic approaches to risk and compliance in relation to study design and data collection and interpretation.
K5: Communication and influencing techniques and strategies, both written and oral (including presenting).
K6: Leadership and management techniques and strategies, including coaching and mentoring techniques.
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.
K8: Learning and development strategies, to enable personal and professional development, including giving and receiving feedback and critical reflection.
K9: The importance of continuing personal and professional development and the role of critical reflection in maintaining fitness to practice.
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).
K11: Ethics in clinical and non-clinical research.
K12: Methods to safely store and handle data in line with national and international data protection and cyber security regulations.
Skills
S1: Interpret, apply and comply with legislation, statutory frameworks, professional codes of practice and guidance, including quality control.
S2: Select and perform the appropriate statistical technique that are commonly used in medical research relevant to the given data set and objective.
S3: Use statistical software (SAS® and R or other appropriate software) to perform the required statistical methods that are commonly used in medical research.
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).
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).
S6: Adapt communication technique when communicating statistical concepts to different audiences including people from a non-scientific background.
S7: Critique technical documents affecting projects they are working on, written by other professionals (e.g. medical writers, study directors, project managers, medical consultants).
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.
S9: Identify issues that can affect projects, finding solutions that meet the commercial demands of the business environment.
S10: Lead projects to completion within agreed and defined timescales and project parameters.
S11: Work within limits of personal and professional competence, justifying and taking responsibility for own actions and seeking advice when required.
S12: Search and critically appraise scientific literature, including literature on new and emerging methods and techniques relevant to medical statistics.
S13: Evaluate new statistical methodologies relevant to medical statistics.
S14: Facilitate learning and provide feedback to others as appropriate.
S15: Critically review own practice and identify areas for personal and professional development.
S16: Collaborate with other professionals to deliver mutually agreed outcomes.
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.
Behaviours
B1: Be open, honest, compassionate, act with integrity at all times, observe duty of candour and maintain confidentiality.
B2: Be respectful, non-judgemental and engage with people in an inclusive and non-discriminatory manner.
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.
B4: Be adaptable and able to respond professionally to all feedback.
B5: Be prepared to challenge and/or report inappropriate behaviours and practices, using established procedures.
B6: Take a proactive approach to own personal wellbeing, and that of others, reporting concerns as appropriate.
Duty 1
DUTY: 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
DUTY: Calculate appropriate sample size in medical research to answer the medical research question of interest.
K1
K3
K11
S3
B3
B5
Duty 3
DUTY: Produce technical writing in medical research
K1
K5
K10
S1
S2
S5
S6
S8
B3
B4
Duty 4
DUTY: 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
DUTY: Select and apply statistical methods applicable for medical research and interpret results
K1
K4
K10
S1
S2
S3
S5
B3
Duty 6
DUTY: Carry out data visualisation for reporting of medical research:
K1
S2
S4
B3
Duty 7
DUTY: Critically review medical scientific literature and contribute to ongoing medical research publications
K1
S2
S7
S12
S13
S17
B4
Duty 8
DUTY: 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
DUTY: 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
DUTY: Develop self and others through demonstration of best practice by effective coaching, mentoring, teaching and training.
