Anjum Mulla

Product Engineer

Satara Taluka, Maharashtra, India10 yrs 10 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

Over five years of experience in clinical trials.
Expertise in biostatistics and statistical analysis.
Strong mentoring and team management skills.

Stackforce AI infers this person is a Biostatistician with extensive experience in healthcare and consumer research.

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Skills

Core Skills

BiostatisticsClinical Trials

Other Skills

BioequivalenceClinical Data ManagementClinical ResearchData AnalysisHaving knowledge of statistical tests which are used in BE and Clinical Trials.R (Programming Language)R softwareRandomization schedule generationRandomization schedule preparationSAP developmentSAS ProgrammingSPSS and Microsoft office.Sample size calculationsSample size estimationStandard Operating Procedure (SOP)

About

More than five years of experience in handling of clinical trials projects in various type of therapeutic areas , research studies and BABE studies. Have experience in the area of survey, consumer & sensory analysis studies also. Well versed with the statistical considerations necessary for analysis and reporting of various statistical studies. Considerable exposure in handling and performing statistical analysis along with sound knowledge of R, SAS and SPSS software, useful in analysis and reporting of the clinical studies as per the sponsor and regulatory requirements. Responsible for the collation, evaluation, interpretation and presentation of quantitative & qualitative data to help make decisions. Provide insights, recommendations and advice on the strategy and ensuring that statistical concepts are explained in a way the client can understand

Experience

Pharma-stats

4 roles

Lead Biostatistician

Promoted

May 2024 – Present · 1 yr 10 mos

1. Lead & oversee complex biostatistical projects & analyses.
2. Provide strategic direction & innovative solutions to enhance project outcomes
3. Continue mentoring & developing team members to achieve their full potential.
4. Strengthen client relationships through effective communication & collaboration.
5. Drive the biostatistics function within organisation with a focus on excellence & innovation.

BiostatisticsClinical TrialsData AnalysisR (Programming Language)Team Managementknowledge of SAS programming+2

Senior Biostatistician

Jan 2022 – Jun 2024 · 2 yrs 5 mos

Biostatistician III

Jan 2021 – Jan 2022 · 1 yr

Lead collaboratively within a framework of study teams. Perform and review the statistical design, sample size calculations, development of statistical analysis plans and query management for studies. Apply innovative thinking in the design and analysis of clinical studies by bringing creative ideas for problem-solving. Interact with all levels of management.

Senior Executive Biostatistician

Jan 2019 – Jan 2021 · 2 yrs

Responsibilities :
Sample size estimation for different designs of clinical studies
Randomization schedule generation
Statistical Analysis Plan (SAP) writing
Protocol inputs in clinical study
Statistical analysis of clinical study
PK analysis for early phase and bioequivalence study
Statistical report preparation
Perform validation and codes of the SAS programs, analysis datasets, tables, listing and figures
Review of CRF and its annotations, database data specifications, statistical analysis plan (SAP) and TLF mock shells
SOP preparation
Contribute to project level activities as needed

Freelance, self-employed

Biostatistician

Sep 2016 – Dec 2018 · 2 yrs 3 mos · Pune, Maharashtra

Responsibilities :
Sample size estimation for different designs of clinical and non-clinical studies
Randomization schedule generation for non-clinical studies.
Statistical inputs in Research projects of PhD and medical students.
Statistical analysis of PhD and medical student’s Research projects.

Cytel

Biostatistician

Nov 2014 – Apr 2016 · 1 yr 5 mos · Pune Area, India

Responsibilities :
Validate analysis datasets & TLFs using various statistical tools.
Perform statistical analysis according to the specifications to create analysis datasets & TLFs using various statistical methods and tools.
Develop SAP and statistical reports.
Prepare Randomization schedule and Sample size calculation.
Review and ensure internal consistency within & among tables, listings & figures of statistical reports.
Statistical analysis on Skin care, Oral care, Hair care and Consumer Survey studies.
Maintain quality and timeliness of assigned project work.
Act as Study lead and be responsible for project deliverables on time.
Plan and lead Defect prevention meeting in order to reduce validation and review findings.
Take regular backup of ongoing studies using backup software.